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1.
Asian Nurs Res (Korean Soc Nurs Sci) ; 15(5): 345-352, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1594617

ABSTRACT

PURPOSE: The purpose of this study was to develop a novel mouth contactless breathing exercise solution based on virtual reality (VR), and to test its feasibility. METHODS: We developed the Virtual Reality-based Breathing Exercise System (VR-BRES), a self-regulating biofeedback breathing exercise with gaming characteristics and a soft stretch sensor. The feasibility and efficacy of the VR-BRES prototype were investigated through a randomized crossover trial. Fifty healthy adults participated in the trial, and their respiratory parameters and user evaluation of the VR-BRES were compared with conventional deep breathing (CDB) exercises. RESULTS: The respiratory parameters, forced vital capacity (Z = 4.82, 4.95, p < .001), forced expiratory volume in one second (t = 6.02, 6.26, p < .001), and peak expiratory flow (t = 5.35, 5.68, p < .001) were significantly higher during breathing exercises using the VR-BRES. User evaluation was also significantly higher for the VR-BRES in terms of efficiency (Z = 3.86, p < .001), entertainingness (Z = 5.00, p < .001), and intention to use (Z = 3.22, p = .001) compared to CDB. However, there was no difference in convenience between the two methods (Z = -0.90, p = .369). CONCLUSION: The VR-BRES has the potential to be an efficient breathing exercise solution. We recommend a clinical study that evaluates the effects of the VR-BRES for a certain period of time for people who need breathing exercises.


Subject(s)
Virtual Reality , Adult , Breathing Exercises , Cross-Over Studies , Feasibility Studies , Humans , Mouth
2.
BMC Infect Dis ; 21(1): 1275, 2021 Dec 20.
Article in English | MEDLINE | ID: covidwho-1582104

ABSTRACT

BACKGROUND: To investigate the association of primary acute cerebral venous thrombosis (CVT) with COVID-19 vaccination through complete ascertainment of all diagnosed CVT in the population of Scotland. METHODS: Case-crossover study comparing cases of CVT recently exposed to vaccination (1-14 days after vaccination) with cases less recently exposed. Cases in Scotland from 1 December 2020 were ascertained through neuroimaging studies up to 17 May 2021 and diagnostic coding of hospital discharges up to 28 April 2021, linked to national vaccination records. The main outcome measure was primary acute CVT. RESULTS: Of 50 primary acute CVT cases, 29 were ascertained only from neuroimaging studies, 2 were ascertained only from hospital discharges, and 19 were ascertained from both sources. Of these 50 cases, 14 had received the Astra-Zeneca ChAdOx1 vaccine and 3 the Pfizer BNT162b2 vaccine. The incidence of CVT per million doses in the first 14 days after vaccination was 2.2 (95% credible interval 0.9 to 4.1) for ChAdOx1 and 1 (95% credible interval 0.1 to 2.9) for BNT162b2. The rate ratio for CVT associated with exposure to ChAdOx1 in the first 14 days compared with exposure 15-84 days after vaccination was 3.2 (95% credible interval 1.1 to 9.5). CONCLUSIONS: These findings support a causal association between CVT and the AstraZeneca vaccine. The absolute risk of post-vaccination CVT in this population-wide study in Scotland was lower than has been reported for populations in Scandinavia and Germany; the explanation for this is not clear.


Subject(s)
COVID-19 , Venous Thrombosis , COVID-19 Vaccines , Cross-Over Studies , Humans , Neuroimaging , SARS-CoV-2 , Scotland/epidemiology , Vaccination , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/epidemiology
4.
BMC Med Educ ; 21(1): 583, 2021 Nov 17.
Article in English | MEDLINE | ID: covidwho-1523304

ABSTRACT

BACKGROUND: Pharmacy practice education requires the development of proficiencies and an understanding of clinical microbiology. Learning in this area could be delivered using practical laboratory exercises, or potentially, simulation-based education. Simulation has previously successfully enhanced learning in health professional education. The current global climate due to COVID-19 has further highlighted the important role of technology-enhanced learning in delivering outcomes that meet the requisite learning objectives of a course. The aim of the present study was to compare the impact of a commercially available virtual microbiology simulation (VUMIE™) with a traditional wet laboratory (wetlab) on learner knowledge, skills and confidence in a second-year integrated pharmacotherapeutics course for Bachelor of Pharmacy students. METHODS: A randomised, crossover study was employed to determine whether the simulation intervention (VUMIE™) improves learning outcomes (knowledge, skills and confidence) of pharmacy students, when compared to a traditional wetlab intervention. Each student completed three 1-2 h length sessions, for both the wetlab and VUMIE™ interventions (6 sessions total). Data was collected using surveys deployed at baseline (pre-interventions), post-intervention 1 or 2 (VUMIE™ or wetlab) and endpoint (post-interventions 1 and 2). Statistical analysis was conducted using SPSS Statistics 25 and Instat™ software. RESULTS: Response rates were approximately 50% at initial survey and approximately 25% at endpoint survey. VUMIE™ produced higher post-intervention knowledge scores for the multiple-choice questions compared to the wetlab, however, the highest score was achieved at endpoint. Both interventions produced statistically significant differences for mean scores compared to baseline (pre-VUMIE™ and wetlab) across the domains of knowledge, skills and confidence. VUMIE™ produced higher post-intervention mean scores for knowledge, skills and confidence compared to post-intervention mean scores for the wetlab, however there was no statistical significance between the mean score for the two interventions, thus the VUMIE™ activity produced learning outcomes comparable to the wetlab activity. CONCLUSION: These findings suggest VUMIE™ provides similar effects on students' knowledge, skills, and confidence as a wetlab. The simulation's implementation was not cost-prohibitive, provided students with a physically and psychologically safe learning environment, and the benefit of being able to repeat activities, supporting deliberate practice.


Subject(s)
COVID-19 , Education, Pharmacy , Pharmacy , Students, Pharmacy , Cross-Over Studies , Humans , SARS-CoV-2
5.
Lancet Infect Dis ; 21(5): 657-667, 2021 05.
Article in English | MEDLINE | ID: covidwho-1510463

ABSTRACT

BACKGROUND: Bacterial sexually transmitted infections (STIs) are highly prevalent among men who have sex with men who use HIV pre-exposure prophylaxis (PrEP), which leads to antimicrobial consumption linked to the emergence of antimicrobial resistance. We aimed to assess use of an antiseptic mouthwash as an antibiotic sparing approach to prevent STIs. METHODS: We invited people using PrEP who had an STI in the past 24 months to participate in this single-centre, randomised, double-blind, placebo-controlled, AB/BA crossover superiority trial at the Institute of Tropical Medicine in Antwerp, Belgium. Using block randomisation (block size eight), participants were assigned (1:1) to first receive Listerine Cool Mint or a placebo mouthwash. They were required to use the study mouthwashes daily and before and after sex for 3 months each and to ask their sexual partners to use the mouthwash before and after sex. Participants were screened every 3 months for syphilis, chlamydia, and gonorrhoea at the oropharynx, anorectum, and urethra. The primary outcome was combined incidence of these STIs during each 3-month period, assessed in the intention-to-treat population, which included all participants who completed at least the first 3-month period. Safety was assessed as a secondary outcome. This trial is registered with Clinicaltrials.gov, NCT03881007. FINDINGS: Between April 2, 2019, and March 13, 2020, 343 participants were enrolled: 172 in the Listerine followed by placebo (Listerine-placebo) group and 171 in the placebo followed by Listerine (placebo-Listerine) group. The trial was terminated prematurely because of the COVID-19 pandemic. 151 participants completed the entire study, and 89 completed only the first 3-month period. 31 participants withdrew consent, ten were lost to follow-up, and one acquired HIV. In the Listerine-placebo group, the STI incidence rate was 140·4 per 100 person-years during the Listerine period, and 102·6 per 100 person-years during the placebo period. In the placebo-Listerine arm, the STI incidence rate was 133·9 per 100 person-years during the placebo period, and 147·5 per 100 person-years during the Listerine period. We did not find that Listerine significantly reduced STI incidence (IRR 1·17, 95% CI 0·84-1·64). Numbers of adverse events were not significantly higher than at baseline and were similar while using Listerine and placebo. Four serious adverse events (one HIV-infection, one severe depression, one Ludwig's angina, and one testicular carcinoma) were not considered to be related to use of mouthwash. INTERPRETATION: Our findings do not support the use of Listerine Cool Mint as a way to prevent STI acquisition among high-risk populations. FUNDING: Belgian Research Foundation - Flanders (FWO 121·00).


Subject(s)
Anti-Bacterial Agents/administration & dosage , HIV Infections/prevention & control , Homosexuality, Male , Mouthwashes , Pre-Exposure Prophylaxis , Sexually Transmitted Diseases/prevention & control , Adult , Cross-Over Studies , Double-Blind Method , Humans , Incidence , Male , Middle Aged , Sexually Transmitted Diseases/epidemiology
6.
Sci Total Environ ; 806(Pt 3): 151349, 2022 Feb 01.
Article in English | MEDLINE | ID: covidwho-1487964

ABSTRACT

BACKGROUND: Ventilation has emerged as an important strategy to reduce indoor aerosol transmission of coronavirus disease 2019. Indoor air carbon dioxide (CO2) concentrations are a surrogate measure of respiratory pathogen transmission risk. OBJECTIVES: To determine whether CO2 monitors are necessary and effective to improve ventilation in hospitals. METHODS: A randomized, placebo (sham)-controlled, crossover, open label trial. Between February and May 2021, we placed CO2 monitors in twelve double-bed patient rooms across two geriatric wards. Staff were instructed to open windows, increase the air exchange rate and reduce room crowding to maintain indoor air CO2 concentrations ≤800 parts per million (ppm). RESULTS: CO2 levels increased during morning care and especially in rooms housing couples (rooming-in). The median (interquartile range, IQR) time/day with CO2 concentration > 800 ppm (primary outcome) was 110 min (IQR 47-207) at baseline, 82 min (IQR 12-226.5) during sham periods, 78 min (IQR 20-154) during intervention periods and 140 min (IQR 19.5-612.5) post-intervention. The intervention period only differed significantly from the post-intervention period (P = 0.02), mainly due to an imbalance in rooming-in. Significant but small differences were observed in secondary outcomes of time/day with CO2 concentrations > 1000 ppm and daily peak CO2 concentrations during the intervention vs. baseline and vs. the post-intervention period, but not vs. sham. Staff reported cold discomfort for patients as the main barrier towards increasing ventilation. DISCUSSION: Indoor air CO2 concentrations in hospital rooms commonly peaked above recommended levels, especially during morning care and rooming-in. There are many possible barriers towards implementing CO2 monitors to improve ventilation in a real-world hospital setting. A paradigm shift in hospital infection control towards adequate ventilation is warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04770597.


Subject(s)
Air Pollution, Indoor , COVID-19 , Aged , Air Pollution, Indoor/analysis , Carbon Dioxide/analysis , Cross-Over Studies , Hospitals , Humans , SARS-CoV-2 , Ventilation
7.
Int J Environ Res Public Health ; 18(20)2021 10 14.
Article in English | MEDLINE | ID: covidwho-1470836

ABSTRACT

COVID-19 transmission is prevalent during ice-hockey; however, it is unknown whether wearing face masks as a mitigation strategy affects hockey players' performance. We used a randomized cross-over study to compare wearing a surgical mask to a sham mask (control) in youth hockey players (21 males, 5 females, 11.7 ± 1.6 y) during a simulated hockey period (cycle ergometry; six shifts of 20 s of "easy" pedaling (40% peak power), 10 s of "hard" pedaling (95% peak power), 20 s of "easy" pedaling, with shifts separated by 5 min rests). A seventh shift involved two 20 s Wingate tests separated by 40 s rest. Heart rate, arterial oxygen saturation and vastus lateralis tissue oxygenation index (hemoglobin saturation/desaturation) was assessed each shift. On-ice testing was conducted with the maximal Yo-Yo intermittent recovery test. No differences between mask and control conditions for performance were found (Wingate average power: 245 ± 93 vs. 237 ± 93 W, Peak power: 314 ± 116 vs. 304 ± 115 W, on-ice distance: 274 ± 116 vs. 274 ± 110 m) and for heart rate or arterial oxygen saturation during simulated hockey shifts. Tissue oxygenation index was lower from shifts one to six for males (p < 0.05) and shift seven for females (p < 0.01) while wearing a mask. Wearing a face mask had no effect on performance in hockey players with only minor effects on muscle oxygenation. ClinicalTrials.gov (NCT04874766) (accessed on 6 May 2021).


Subject(s)
COVID-19 , Hockey , Adolescent , Cross-Over Studies , Exercise Test , Female , Humans , Male , Masks , SARS-CoV-2
8.
J Clin Invest ; 131(20)2021 10 15.
Article in English | MEDLINE | ID: covidwho-1470551

ABSTRACT

BACKGROUNDCOVID-19 convalescent plasma (CCP) has been considered a treatment option for COVID-19. This trial assessed the efficacy of a neutralizing antibody containing high-dose CCP in hospitalized adults with COVID-19 requiring respiratory support or intensive care treatment.METHODSPatients (n = 105) were randomized 1:1 to either receive standard treatment and 3 units of CCP or standard treatment alone. Control group patients with progress on day 14 could cross over to the CCP group. The primary outcome was a dichotomous composite outcome of survival and no longer fulfilling criteria for severe COVID-19 on day 21.ResultsThe primary outcome occurred in 43.4% of patients in the CCP group and 32.7% in the control group (P = 0.32). The median time to clinical improvement was 26 days in the CCP group and 66 days in the control group (P = 0.27). The median time to discharge from the hospital was 31 days in the CCP group and 51 days in the control group (P = 0.24). In the subgroup that received a higher cumulative amount of neutralizing antibodies, the primary outcome occurred in 56.0% of the patients (vs. 32.1%), with significantly shorter intervals to clinical improvement (20 vs. 66 days, P < 0.05) and to hospital discharge (21 vs. 51 days, P = 0.03) and better survival (day-60 probability of survival 91.6% vs. 68.1%, P = 0.02) in comparison with the control group.ConclusionCCP added to standard treatment was not associated with a significant improvement in the primary and secondary outcomes. A predefined subgroup analysis showed a significant benefit of CCP among patients who received a larger amount of neutralizing antibodies.Trial registrationClinicalTrials.gov NCT04433910.FundingBundesministerium für Gesundheit (German Federal Ministry of Health): ZMVI1-2520COR802.


Subject(s)
COVID-19/therapy , SARS-CoV-2 , Aged , Antibodies, Neutralizing/administration & dosage , Antibodies, Neutralizing/therapeutic use , Antibodies, Viral/administration & dosage , Antibodies, Viral/therapeutic use , COVID-19/immunology , COVID-19/physiopathology , Combined Modality Therapy , Cross-Over Studies , Female , Humans , Immunization, Passive/adverse effects , Immunization, Passive/methods , Kaplan-Meier Estimate , Male , Middle Aged , Pandemics , Prospective Studies , SARS-CoV-2/immunology , Severity of Illness Index , Treatment Outcome
9.
Trials ; 22(1): 694, 2021 Oct 11.
Article in English | MEDLINE | ID: covidwho-1463261

ABSTRACT

OBJECTIVES: It is currently thought that most-but not all-individuals infected with SARS-CoV-2 develop symptoms, but the infectious period starts on average 2 days before the first overt symptoms appear. It is estimated that pre- and asymptomatic individuals are responsible for more than half of all transmissions. By detecting infected individuals before they have overt symptoms, wearable devices could potentially and significantly reduce the proportion of transmissions by pre-symptomatic individuals. Using laboratory-confirmed SARS-CoV-2 infections (detected via serology tests [to determine if there are antibodies against the SARS-CoV-2 in the blood] or SARS-CoV-2 infection tests such as polymerase chain reaction [PCR] or antigen tests) as the gold standard, we will determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the following two algorithms to detect first time SARS-CoV-2 infection including early or asymptomatic infection: • The algorithm using Ava bracelet data when coupled with self-reported Daily Symptom Diary data (Wearable + Symptom Data Algo; experimental condition) • The algorithm using self-reported Daily Symptom Diary data alone (Symptom Only Algo; control condition) In addition, we will determine which of the two algorithms has superior performance characteristics for detecting SARS-CoV-2 infection including early or asymptomatic infection as confirmed by SARS-CoV-2 virus testing. TRIAL DESIGN: The trial is a randomized, single-blinded, two-period, two-sequence crossover trial. The study will start with an initial learning phase (maximum of 3 months), followed by period 1 (3 months) and period 2 (3 months). Subjects entering the study at the end of the recruitment period may directly start with period 1 and will not be part of the learning phase. Each subject will undergo the experimental condition (the Wearable + Symptom Data Algo) in either period 1 or period 2 and the control condition (Symptom Only Algo) in the other period. The order will be randomly assigned, resulting in subjects being allocated 1:1 to either sequence 1 (experimental condition first) or sequence 2 (control condition first). Based on demographics, medical history and/or profession, each subject will be stratified at baseline into a high-risk and normal-risk group within each sequence. PARTICIPANTS: The trial will be conducted in the Netherlands. A target of 20,000 subjects will be enrolled. Based on demographics, medical history and/or profession, each subject will be stratified at baseline into a high-risk and normal-risk group within each sequence. This results in approximately 6500 normal-risk individuals and 3500 high-risk individuals per sequence. Subjects will be recruited from previously studied cohorts as well as via public campaigns and social media. All data for this study will be collected remotely through the Ava COVID-RED app, the Ava bracelet, surveys in the COVID-RED web portal and self-sampling serology and PCR kits. More information on the study can be found in www.covid-red.eu . During recruitment, subjects will be invited to visit the COVID-RED web portal. After successfully completing the enrolment questionnaire, meeting eligibility criteria and indicating interest in joining the study, subjects will receive the subject information sheet and informed consent form. Subjects can enrol in COVID-RED if they comply with the following inclusion and exclusion criteria: Inclusion criteria: • Resident of the Netherlands • At least 18 years old • Informed consent provided (electronic) • Willing to adhere to the study procedures described in the protocol • Must have a smartphone that runs at least Android 8.0 or iOS 13.0 operating systems and is active for the duration of the study (in the case of a change of mobile number, the study team should be notified) • Be able to read, understand and write Dutch Exclusion criteria: • Previous positive SARS-CoV-2 test result (confirmed either through PCR/antigen or antibody tests; self-reported) • Current suspected (e.g. waiting for test result) COVID-19 infection or symptoms of a COVID-19 infection (self-reported) • Participating in any other COVID-19 clinical drug, vaccine or medical device trial (self-reported) • Electronic implanted device (such as a pacemaker; self-reported) • Pregnant at the time of informed consent (self-reported) • Suffering from cholinergic urticaria (per the Ava bracelet's user manual; self-reported) • Staff involved in the management or conduct of this study INTERVENTION AND COMPARATOR: All subjects will be instructed to complete the Daily Symptom Diary in the Ava COVID-RED app daily, wear their Ava bracelet each night and synchronize it with the app each day for the entire period of study participation. Provided with wearable sensor and/or self-reported symptom data within the last 24 h, the Ava COVID-RED app's underlying algorithms will provide subjects with a real-time indicator of their overall health and well-being. Subjects will see one of three messages, notifying them that no seeming deviations in symptoms and/or physiological parameters have been detected; some changes in symptoms and/or physiological parameters have been detected and they should self-isolate; or alerting them that deviations in their symptoms and/or physiological parameters could be suggestive of a potential COVID-19 infection and to seek additional testing. We will assess the intraperson performance of the algorithms in the experimental condition (Wearable + Symptom Data Algo) and control conditions (Symptom Only Algo). Note that both algorithms will also instruct to seek testing when any SARS-CoV-2 symptoms are reported in line with those defined by the Dutch national institute for public health and the environment 'Rijksinstituut voor Volksgezondheid en Milieu' (RIVM) guidelines. MAIN OUTCOMES: The trial will evaluate the use and performance of the Ava COVID-RED app and Ava bracelet, which uses sensors to measure breathing rate, pulse rate, skin temperature and heart rate variability for the purpose of early and asymptomatic detection and monitoring of SARS-CoV-2 in general and high-risk populations. Using laboratory-confirmed SARS-CoV-2 infections (detected via serology tests, PCR tests and/or antigen tests) as the gold standard, we will determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for each of the following two algorithms to detect first-time SARS-CoV-2 infection including early or asymptomatic infection: the algorithm using Ava bracelet data when coupled with the self-reported Daily Symptom Diary data and the algorithm using self-reported Daily Symptom Diary data alone. In addition, we will determine which of the two algorithms has superior performance characteristics for detecting SARS-CoV-2 infection including early or asymptomatic infection as confirmed by SARS-CoV-2 virus testing. The protocol contains an additional twenty secondary and exploratory objectives which address, among others, infection incidence rates, health resource utilization, symptoms reported by SARS-CoV-2-infected participants and the rate of breakthrough and asymptomatic SARS-CoV-2 infections among individuals vaccinated against COVID-19. PCR or antigen testing will occur when the subject receives a notification from the algorithm to seek additional testing. Subjects will be advised to get tested via the national testing programme and report the testing result in the Ava COVID-RED app and a survey. If they cannot obtain a test via the national testing programme, they will receive a nasal swab self-sampling kit at home, and the sample will be tested by PCR in a trial-affiliated laboratory. In addition, all subjects will be asked to take a capillary blood sample at home at baseline (between month 0 and 3.5 months after the start of subject recruitment), at the end of the learning phase (month 3; note that this sampling moment is skipped if a subject entered the study at the end of the recruitment period), period 1 (month 6) and period 2 (month 9). These samples will be used for SARS-CoV-2-specific antibody testing in a trial-affiliated laboratory, differentiating between antibodies resulting from a natural infection and antibodies resulting from COVID-19 vaccination (as vaccination will gradually be rolled out during the trial period). Baseline samples will only be analysed if the sample collected at the end of the learning phase is positive, or if the subject entered the study at the end of the recruitment period, and samples collected at the end of period 1 will only be analysed if the sample collected at the end of period 2 is positive. When subjects obtain a positive PCR/antigen or serology test result during the study, they will continue to be in the study but will be moved into a so-called COVID-positive mode in the Ava COVID-RED app. This means that they will no longer receive recommendations from the algorithms but can still contribute and track symptom and bracelet data. The primary analysis of the main objective will be executed using the data collected in period 2 (months 6 through 9). Within this period, serology tests (before and after period 2) and PCR/antigen tests (taken based on recommendations by the algorithms) will be used to determine if a subject was infected with SARS-CoV-2 or not. Within this same time period, it will be determined if the algorithms gave any recommendations for testing. The agreement between these quantities will be used to evaluate the performance of the algorithms and how these compare between the study conditions. RANDOMIZATION: All eligible subjects will be randomized using a stratified block randomization approach with an allocation ratio of 1:1 to one of two sequences (experimental condition followed by control condition or control condition followed by experimentalcondition). Based on demographics, medical history and/or profession, each subject will be stratified at baseline into a high-risk and normal-risk group within each sequence, resulting in approximately equal numbers of high-risk and normal-risk individuals between the sequences. BLINDING (MASKING): In this study, subjects will be blinded to the study condition and randomization sequence. Relevant study staff and the device manufacturer will be aware of the assigned sequence. The subject will wear the Ava bracelet and complete the Daily Symptom Diary in the Ava COVID-RED app for the full duration of the study, and they will not know if the feedback they receive about their potential infection status will only be based on the data they entered in the Daily Symptom Diary within the Ava COVID-RED app or based on both the data from the Daily Symptom Diary and the Ava bracelet. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 20,000 subjects will be recruited and randomized 1:1 to either sequence 1 (experimental condition followed by control condition) or sequence 2 (control condition followed by experimental condition), taking into account their risk level. This results in approximately 6500 normal-risk and 3500 high-risk individuals per sequence. TRIAL STATUS: Protocol version: 3.0, dated May 3, 2021. Start of recruitment: February 19, 2021. End of recruitment: June 3, 2021. End of follow-up (estimated): November 2021 TRIAL REGISTRATION: The Netherlands Trial Register on the 18th of February, 2021 with number NL9320 ( https://www.trialregister.nl/trial/9320 ) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.


Subject(s)
COVID-19 , Wearable Electronic Devices , Adolescent , COVID-19 Vaccines , Cross-Over Studies , Humans , Prospective Studies , Randomized Controlled Trials as Topic , SARS-CoV-2
10.
Medicine (Baltimore) ; 100(40): e27444, 2021 Oct 08.
Article in English | MEDLINE | ID: covidwho-1462563

ABSTRACT

ABSTRACT: Severe acute respiratory syndrome coronavirus-2 may cause low oxygen saturation (SpO2) and respiratory failure in patients with coronavirus disease (COVID-19). Hence, increased SpO2 levels in COVID-19 patients could be crucial for their quality of life and recovery. This study aimed to demonstrate that a 30-minute single session of dorsal low-field thoracic magnetic stimulation (LF-ThMS) can be employed to increase SpO2 levels in COVID-19 patients significantly. Furthermore, we hypothesized that the variables associated with LF-ThMS, such as frequency, magnetic flux density, and temperature in the dorsal thorax, might be correlated to SpO2 levels in these patients.Here we employed an LF-ThMS device to noninvasively deliver a pulsed magnetic field from 100 to 118 Hz and 10.5 to 13.1 milliTesla (i.e., 105 to 131 Gauss) to the dorsal thorax. These values are within the intensity range of several pulsed electromagnetic field devices employed in physical therapy worldwide. We designed a single-blind, sham-controlled, crossover study on 5 COVID-19 patients who underwent 2 sessions of the study (real and sham LF-ThMS) and 12 patients who underwent only the real LF-ThMS.We found a statistically significant positive correlation between magnetic flux density, frequency, or temperature, associated with the real LF-ThMS and SpO2 levels in all COVID-19 patients. However, the 5 patients in the sham-controlled study did not exhibit a significant change in their SpO2 levels during sham stimulation. The employed frequencies and magnetic flux densities were safe for the patients. We did not observe adverse events after the LF-ThMS intervention.This study is a proof-of-concept that a single session of LF-ThMS applied for 30 minutes to the dorsal thorax of 17 COVID-19 patients significantly increased their SpO2 levels. However, future research will be needed to understand the physiological mechanisms behind this finding.The study was registered at ClinicalTrials.gov (Identifier: NCT04895267, registered on May 20, 2021) retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT04895267.


Subject(s)
COVID-19/therapy , Magnetic Field Therapy/methods , Oxygen/blood , Adult , Aged , Aged, 80 and over , Cross-Over Studies , Female , Humans , Male , Middle Aged , Quality of Life , SARS-CoV-2 , Single-Blind Method , Thorax
11.
Int J Environ Res Public Health ; 18(19)2021 09 23.
Article in English | MEDLINE | ID: covidwho-1463631

ABSTRACT

As the primary environmental cue for the body's master biological clock, light-dark patterns are key for circadian alignment and are ultimately fundamental to multiple dimensions of health including sleep and mental health. Although daylight provides the proper qualities of light for promoting circadian alignment, our modern indoor lifestyles offer fewer opportunities for adequate daylight exposure. This field study explores how increasing circadian-effective light in residences affects circadian phase, sleep, vitality, and mental health. In this crossover study, 20 residents spent one week in their apartments with electrochromic glass windows and another week with functionally standard windows with blinds. Calibrated light sensors revealed higher daytime circadian-effective light levels with the electrochromic glass windows, and participants exhibited consistent melatonin onset, a 22-min earlier sleep onset, and higher sleep regularity. In the blinds condition, participants exhibited a 15-min delay in dim light melatonin onset, a delay in subjective vitality throughout the day, and an overall lower positive affect. This study demonstrates the impact of daytime lighting on the physiological, behavioral, and subjective measures of circadian health in a real-world environment and stresses the importance of designing buildings that optimize daylight for human health and wellbeing.


Subject(s)
Melatonin , Mental Health , Adult , Circadian Rhythm , Cross-Over Studies , Humans , Sleep
12.
Pharmacol Res Perspect ; 9(5): e00846, 2021 10.
Article in English | MEDLINE | ID: covidwho-1460269

ABSTRACT

The COVID-19 pandemic has forced clinical studies to accommodate imposed limitations. In this study, the bioequivalence part could not be conducted as planned. Thus, the aim was to demonstrate bioequivalence, using an adaptive study design, of tadalafil in fixed-dose combination (FDC) tablets of macitentan/tadalafil with single macitentan and tadalafil (Canadian-sourced) tablets and assess the effect of food on FDC tablets in healthy subjects. This Phase 1, single-center, open-label, single-dose, two-part, two-period, randomized, crossover study enrolled 62 subjects. Tadalafil bioequivalence as part of FDC of macitentan/tadalafil (10/40 mg) with single-component tablets of macitentan (10 mg) and tadalafil (40 mg) was determined by pharmacokinetic (PK) assessment under fasted conditions. The effect of food on FDC was evaluated under fed and fasted conditions. Fasted 90% confidence intervals (CIs) for geometric mean ratios (GMRs) were within bioequivalence limits for tadalafil and macitentan. Fed and fasted 90% CIs for area under the curve (AUC) GMR were within bioequivalence limits. However, 90% CIs for maximum plasma concentration (Cmax ) GMR for macitentan and tadalafil were outside bioequivalence limits. One FDC-treated subject experienced a serious adverse event of transient ischemic attack (bioequivalence part). To address pandemic-imposed limitations, an adaptive study design was implemented to demonstrate that the FDC tablet was bioequivalent to the free combination of macitentan and tadalafil (Canadian-sourced). No clinically significant differences in PK were determined between fed and fasted conditions; the FDC formulation could be taken irrespective of meals. The FDC formulation under fasted and fed conditions was well tolerated with no clinically relevant differences in safety profiles between the treatment groups. NCT Number: NCT04235270.


Subject(s)
COVID-19/epidemiology , Fasting/blood , Food-Drug Interactions/physiology , Pyrimidines/blood , Research Design , Sulfonamides/blood , Tadalafil/blood , Adult , COVID-19/prevention & control , Cross-Over Studies , Drug Therapy, Combination , Female , Humans , Male , Middle Aged , Pyrimidines/administration & dosage , Research Design/trends , Sulfonamides/administration & dosage , Tadalafil/administration & dosage , Therapeutic Equivalency , Young Adult
13.
Clin Respir J ; 14(3): 214-221, 2020 Mar.
Article in English | MEDLINE | ID: covidwho-1455532

ABSTRACT

BACKGROUND: Patients with neuromuscular disorders (NMDs) are likely to develop respiratory failure which requires noninvasive ventilation (NIV). Ventilation via a mouthpiece (MPV) is an option to offer daytime NIV. OBJECTIVES: To determine the preferred equipment for MPV by patients with NMDs. METHODS: Two MPV equipment sets were compared in 20 patients with NMDs. Set 1, consisted of a non-dedicated ventilator for MPV (PB560, Covidien) with a plastic angled mouthpiece. Set 2, consisted of a dedicated MPV ventilator (Trilogy 100, Philips Respironics) without backup rate and kiss trigger combined with a silicone straw mouthpiece. The Borg dyspnea score, ventilator free time, transcutaneous oxygen saturation (SpO2) and carbon dioxide tension (TcCO2 ) were recorded with and without MPV. Patient perception was assessed by a 17-items list. RESULTS: Carbon dioxide tension measurements and total perception score were not different between the two MPV sets. Dyspnea score was lower with the non-dedicated versus dedicated equipment, 1 (0.5) versus 3 (1-6), P < 0.01. All patients with a ventilator free time lower than 6 hours preferred a set backup rate rather than a kiss trigger. Sixty five percent of patients preferred the commercial arm support and 55% preferred the plastic angled mouthpiece. CONCLUSIONS: Dedicated and non-dedicated MPV equipment are deemed effective and comfortable. Individualization of arm support and mouthpiece is advised to ensure success of MPV. A ventilator free time lower than 6 hours seems to be a useful indicator to a priori set a backup rate rather than a rate at zero associated to the kiss trigger.


Subject(s)
Neuromuscular Diseases/complications , Noninvasive Ventilation/instrumentation , Respiratory Insufficiency/therapy , Ventilators, Mechanical/statistics & numerical data , Adolescent , Adult , Blood Gas Monitoring, Transcutaneous/methods , Carbon Dioxide/metabolism , Case-Control Studies , Cross-Over Studies , Dyspnea/diagnosis , Equipment Design , Female , Humans , Male , Perception , Time Factors , Ventilators, Mechanical/trends , Young Adult
14.
J Neurophysiol ; 126(4): 1221-1233, 2021 Oct 01.
Article in English | MEDLINE | ID: covidwho-1381185

ABSTRACT

Frontal-midline theta (FMT) oscillations are increased in amplitude during cognitive control tasks. Since these tasks often conflate cognitive control and cognitive effort, it remains unknown if FMT amplitude maps onto cognitive control or effort. To address this gap, we utilized the glucose facilitation effect to manipulate cognitive effort without changing cognitive control demands. We performed a single-blind, crossover human study in which we provided participants with a glucose drink (control session: volume-matched water) to reduce cognitive effort and improve performance on a visuospatial working memory task. Following glucose consumption, participants performed the working memory task at multiple time points of a 3-h window to sample across the rise and fall of blood glucose. Using high-density electroencephalography (EEG), we calculated FMT amplitude during the delay period of the working memory task. Source localization analysis revealed that FMT oscillations originated from bilateral prefrontal cortex. We found that glucose increased working memory accuracy during the high working memory load condition but decreased FMT amplitude. The decrease in FMT amplitude coincided with both peak blood glucose elevation and peak performance enhancement for glucose relative to water. Therefore, the positive association between glucose consumption and task performance provided causal evidence that the amplitude of FMT oscillations may correspond to cognitive effort, rather than cognitive control. Due to the COVID-19 pandemic, data collection was terminated prematurely; the preliminary nature of these findings due to small sample size should be contextualized by rigorous experimental design and use of a novel causal perturbation to dissociate cognitive effort and cognitive control.NEW & NOTEWORTHY We investigated whether frontal-midline theta (FMT) oscillations tracked with cognitive control or cognitive effort by simultaneous manipulation of cognitive control demands in a working memory task and causal perturbation of cognitive effort using glucose consumption. Facilitation of performance from glucose consumption corresponded with decreased FMT amplitude, which provided preliminary causal evidence for a relationship between FMT amplitude with cognitive effort.


Subject(s)
Cognition , Frontal Lobe/physiology , Memory, Short-Term/physiology , Theta Rhythm , Adult , Blood Glucose , Cross-Over Studies , Electroencephalography , Female , Glucose/administration & dosage , Glucose/metabolism , Humans , Male , Middle Aged , Pilot Projects , Spatial Processing/physiology , Young Adult
16.
Adipocyte ; 10(1): 408-411, 2021 12.
Article in English | MEDLINE | ID: covidwho-1360282

ABSTRACT

Angiotensin converting enzyme-2 (ACE2) is the cell-surface receptor enabling cellular entry of SARS-CoV-2. ACE2 is highly expressed in adipose tissue (AT), rendering AT a potential SARS-CoV-2 reservoir contributing to massive viral spread in COVID-19 patients with obesity. Although rodent and cell studies suggest that the polyphenol resveratrol alters ACE2, human studies are lacking. Here, we investigated the effects of 30-days resveratrol supplementation on RAS components in AT and skeletal muscle in men with obesity in a placebo-controlled cross-over study. Resveratrol markedly decreased ACE2 (~40%) and leptin (~30%), but did neither alter angiotensinogen, ACE and AT1R expression in AT nor skeletal muscle RAS components. These findings demonstrate that resveratrol supplementation reduces ACE2 in AT, which might dampen SARS-CoV-2 spread in COVID-19.


Subject(s)
Adipose Tissue/metabolism , Angiotensin-Converting Enzyme 2/metabolism , Resveratrol/administration & dosage , Adipose Tissue/cytology , Angiotensin-Converting Enzyme 2/genetics , COVID-19/pathology , COVID-19/virology , Cross-Over Studies , Dietary Supplements , Double-Blind Method , Down-Regulation/drug effects , Humans , Leptin/genetics , Leptin/metabolism , Male , Middle Aged , Obesity/drug therapy , Obesity/pathology , Placebo Effect , Receptor, Angiotensin, Type 1/genetics , Receptor, Angiotensin, Type 1/metabolism , Resveratrol/pharmacology , SARS-CoV-2/isolation & purification
17.
J Glaucoma ; 30(10): 878-881, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1356729

ABSTRACT

PRECIS: Tape sealing of the face mask can prevent fogging artifacts of visual field testing. Here, we demonstrate that tape sealing can improve visual field scores even when fogging artifacts are not obvious. PURPOSE: The purpose of this study was to demonstrate that visual field scores improve when the face masks are taped to prevent fogging artifacts. METHODS: A Single-center, randomized 2×2 cross-over study. Twenty-six visual fields of 13 patients of the glaucoma outpatient clinic were included. Patients were randomized in either sequence 1 (Octopus visual field examination without tape sealing, followed by examination with tape sealing) or sequence 2 (examination with, followed by without tape sealing). RESULTS: The results for mean defect and square root of loss variance differ significantly in the examination with and without tape sealing [mean difference (without-with) 0.39 dB, 95% confidence interval: 0.07-0.70 dB, P=0.018 and 0.49 dB, 95% confidence interval: 0.19-0.79 dB, P=0.003, respectively]. There was no sequence effect (P=0.967) for mean defect nor the square root of loss variance (P=0.779). A significant effect for period (P=0.023) for mean defect was yielded. CONCLUSION: Tape sealing of face masks during visual field testing prevented fogging artifacts and improved visual field scores even when fogging artifacts were not obvious and should be considered in clinical practice.


Subject(s)
COVID-19 , Visual Fields , Cross-Over Studies , Humans , Intraocular Pressure , Masks , SARS-CoV-2 , Visual Field Tests
19.
Contemp Clin Trials ; 108: 106520, 2021 09.
Article in English | MEDLINE | ID: covidwho-1330680

ABSTRACT

BACKGROUND: Near highway residents are exposed to elevated levels of traffic-related air pollution (TRAP), including ultrafine particles, which are associated with adverse health effects. The efficacy of using in-home air filtration units that reduce exposure and potentially yield health benefits has not been tested in a randomized controlled trial. METHODS: We will conduct a randomized double-blind crossover trial of portable air filtration units for 200 adults 30 years and older who live in near-highway homes in Somerville, MA, USA. We will recruit participants from 172 households. The intervention periods will be one month of true or sham filtration, followed by a one-month wash out period and then a month of the alternate intervention. The primary health outcome will be systolic blood pressure (BP); secondary outcome measures will include diastolic and central BP, C-Reactive Protein (CRP) and D-dimer. Reasons for success or failure of the intervention will be evaluated in a subset of homes using indoor/outdoor monitoring for particulate pollution, personal monitoring, size and composition of particulate pollution, tracking of time spent in the room with the filter, and interviews for qualitative feedback. RESULTS: This trial has begun recruitment and is expected to take 2-3 years to be completed. Recruitment has been particularly challenging because of additional precautions required by the COVID-19 pandemic. DISCUSSION: This study has the potential to shed light on the value of using portable air filtration in homes close to highways to reduce exposure to TRAP and whether doing so has benefits for cardiovascular health.


Subject(s)
COVID-19 , Cardiovascular Diseases , Adult , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Cross-Over Studies , Heart Disease Risk Factors , Humans , Pandemics , Risk Factors , SARS-CoV-2
20.
JAMA Netw Open ; 4(7): e2117809, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1320051

ABSTRACT

Importance: Hospitalized children are at increased risk of influenza-related complications, yet influenza vaccine coverage remains low among this group. Evidence-based strategies about vaccination of vulnerable children during all health care visits are especially important during the COVID-19 pandemic. Objective: To design and evaluate a clinical decision support (CDS) strategy to increase the proportion of eligible hospitalized children who receive a seasonal influenza vaccine prior to inpatient discharge. Design, Setting, and Participants: This quality improvement study was conducted among children eligible for the seasonal influenza vaccine who were hospitalized in a tertiary pediatric health system providing care to more than half a million patients annually in 3 hospitals. The study used a sequential crossover design from control to intervention and compared hospitalizations in the intervention group (2019-2020 season with the use of an intervention order set) with concurrent controls (2019-2020 season without use of an intervention order set) and historical controls (2018-2019 season with use of an order set that underwent intervention during the 2019-2020 season). Interventions: A CDS intervention was developed through a user-centered design process, including (1) placing a default influenza vaccine order into admission order sets for eligible patients, (2) a script to offer the vaccine using a presumptive strategy, and (3) just-in-time education for clinicians addressing vaccine eligibility in the influenza order group with links to further reference material. The intervention was rolled out in a stepwise fashion during the 2019-2020 influenza season. Main Outcomes and Measures: Proportion of eligible hospitalizations in which 1 or more influenza vaccines were administered prior to discharge. Results: Among 17 740 hospitalizations (9295 boys [52%]), the mean (SD) age was 8.0 (6.0) years, and the patients were predominantly Black (n = 8943 [50%]) or White (n = 7559 [43%]) and mostly had public insurance (n = 11 274 [64%]). There were 10 997 hospitalizations eligible for the influenza vaccine in the 2019-2020 season. Of these, 5449 (50%) were in the intervention group, and 5548 (50%) were concurrent controls. There were 6743 eligible hospitalizations in 2018-2019 that served as historical controls. Vaccine administration rates were 31% (n = 1676) in the intervention group, 19% (n = 1051) in concurrent controls, and 14% (n = 912) in historical controls (P < .001). In adjusted analyses, the odds of receiving the influenza vaccine were 3.25 (95% CI, 2.94-3.59) times higher in the intervention group and 1.28 (95% CI, 1.15-1.42) times higher in concurrent controls than in historical controls. Conclusions and Relevance: This quality improvement study suggests that user-centered CDS may be associated with significantly improved influenza vaccination rates among hospitalized children. Stepwise implementation of CDS interventions was a practical method that was used to increase quality improvement rigor through comparison with historical and concurrent controls.


Subject(s)
Child, Hospitalized , Decision Support Systems, Clinical , Influenza Vaccines , Influenza, Human/prevention & control , Patient Discharge , Vaccination Coverage , Adolescent , COVID-19 , Child , Child, Preschool , Cross-Over Studies , Humans , Pandemics , Patient Selection , Pediatrics , SARS-CoV-2 , Seasons , Vaccination
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