Fatigue and Mental Illness Symptoms in Long COVID: Protocol for a Prospective Cohort Multicenter Observational Study.

BACKGROUND: The aftermath of the COVID-19 pandemic continues to affect millions worldwide, resulting in persisting postvirus complaints and impacting peoples' quality of life. Long COVID, characterized by lingering symptoms like fatigue and mental illness, can extend beyond a few months, necessitating further research to understand its implications. OBJECTIVE: This study aims to quantify the degree of physical and psychological fatigue in patients following COVID-19 infection and examine its correlation with mental health disorders. METHODS: Using a consecutive nonrandom sampling technique, we will conduct a prospective cohort multicenter observational study in 5 Portuguese hospitals. Symptomatic adult patients with previous COVID-19 attending follow-up consultations will be enrolled. We will include patients who had mild, moderate, and severe acute disease. We will assess clinical outcomes related to COVID-19, including the type of respiratory support such as high-flow nasal cannula, noninvasive ventilation, and invasive mechanical ventilation. The exclusion criteria will include previous severe psychiatric disorders confirmed by a psychiatrist; refusal or inability to respond to the questionnaire; concomitant neurological disorder; persistent fatigue symptoms during the 6 months before infection; and the need for invasive mechanical ventilation during COVID-19 infection due to a high prevalence of postintensive care syndrome. Our primary outcome is the prevalence of fatigue in patients with post-COVID-19 depression and/or anxiety, as measured by the Chalder Fatigue Scale (CFQ-11) and the Hospital Anxiety and Depression Scale (HADS). The secondary outcomes will include an assessment of health-related quality of life via the EQ-5D questionnaire and an exploration of the prevalence of symptoms of posttraumatic stress disorder (PTSD) using the 14-item Posttraumatic Stress Scale (PTSS-14). We will also examine the association between mental health symptoms and the severity of acute COVID-19. The post-COVID-19 data will be collected at least 6 months after the positive test and no longer than 9 months during the clinical appointment. RESULTS: We expect our multicenter study on patients post COVID-19 to reveal a significant link between mental illness symptoms and both physical and psychological fatigue. Patients with heightened depression and anxiety may report increased levels of fatigue. Additionally, we expect to find persistent PTSD symptoms in a subset of participants, indicating the enduring psychological impact of the virus. CONCLUSIONS: This study may underscore the need for integrated care addressing physical and mental health in patients post COVID-19. The observed connections emphasize the importance of considering mental well-being for long-term health outcomes. Despite study limitations, our findings contribute valuable insights for future treatment strategies and highlight the necessity for comprehensive mental health support in post-COVID-19 care. This research provides valuable insights into the mental health implications of COVID-19 and its impact on post-COVID-19 fatigue and the overall well-being of affected individuals. TRIAL REGISTRATION: ClinicalTrials.gov NCT05323318; https://clinicaltrials.gov/study/NCT05323318. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51820.

Autoinflation compared to ventilation tubes for treating chronic otitis media with effusion.

BACKGROUND: Otitis media with effusion (OME) is the most common cause of acquired hearing loss and surgery in children. Autoinflation has been suggested as an alternative treatment for OME. OBJECTIVES: The aim of the study was to compare treatment outcome with a new autoinflation device versus ventilation tube (VT) surgery or watchful waiting in children with chronic bilateral OME from the waiting list for surgery. METHODS: Forty-five children performed autoinflation during four weeks, forty-five were submitted to VT surgery, and twenty-three were enrolled as control group. Tympanometry was performed in the autoinflation and the control groups and audiometry in all groups. RESULTS: An equivalent hearing improvement was achieved in the autoinflation and the VT group at one (p=.19), six (p=.23) and twelve (p=.31) months with no significant alteration in the control group. In the autoinflation group 80% of the children avoided surgery and no complications were reported compared to 34% complication rate in the VT group. CONCLUSION: Autoinflation achieved an equivalent improvement in hearing thresholds compared to VT surgery for treating OME. SIGNIFICANCE: Autoinflation may be a reasonable first-line treatment for children with OME to potentially avoid surgery.Article Summary: The Moniri autoinflation device is well tolerated and an effective alternative to ventilation tubes for treatment of chronic otitis media with effusion in young children.What's known on this subject: Previous studies have shown that autoinflation may reduce effusion in children with otitis media with effusion; however limited compliance to treatment, lack of adequate hearing evaluation, short follow-up time and also lack of comparative data to ventilation tube surgery have been reported.What this study adds: A new device was developed to allow for the performance of autoinflation in young children. The effect is compared to ventilation tube surgery and equivalent improvement in hearing is achieved in the short and the long-term follow-up.

Mattress and pillow for prone positioning for treatment of obstructive sleep apnoea.

CONCLUSION: The new mattress and pillow for prone positioning (MPP) is efficient in reducing the apnoea-hypopnoea index (AHI) and oxygen desaturation index (ODI) in most patients with obstructive sleep apnoea (OSA), with satisfactory compliance. OBJECTIVE: The aim of the present study was to evaluate the effect of the prone body and head sleep position on severity of disease in patients with OSA after 4 weeks of adaptation to a mattress and pillow facilitating prone positioning. METHODS: Fourteen patients with mild to severe OSA, 11 men and 3 women with a mean AHI of 26 (min, 6; max, 53) and mean ODI of 21 (min, 6; max, 51) were evaluated. Two polysomnographic (PSG) studies were performed. The first PSG study was without any treatment and the second was after 4 weeks of adaptation to the MPP for prone positioning of the body and the head. RESULTS: Mean AHI and ODI decreased from 26 and 21 to 8 and 7, respectively (p < 0.001) with treatment. The mean time spent in the supine position was reduced from 128 to 10 min (p = 0.02) and the prone time increased from 42 to 174 min (p = 0.02) with the MPP. The mean total sleep time was 390 min during the first PSG study night without treatment and 370 min during the second night with the MPP (p = 0.7). Ten patients (71%) reduced their AHI by at least 50% and reached a value < 10 during treatment. All patients managed to sleep on the MPP for > 4 h per night during the 4-week study.

The effect of the prone sleeping position on obstructive sleep apnoea.

CONCLUSIONS: Prone positioning reveals promising results in improving the apnoea-hypopnoea index (AHI) and oxygen desaturation index (ODI) in patients with obstructive sleep apnoea (OSA). OBJECTIVE: To evaluate the effect of the prone position on OSA. METHODS: Thirty-two patients with mild to severe OSA were included in the study. This was a two-night study to evaluate the effect of the prone position on OSA; a first night in a normal bed with optional positioning and a second night on a mattress and pillow facilitating prone positioning. RESULTS: A total of 27 patients, 22 males and 5 females, with a mean age of 51 years, 15 patients with positional OSA (POSA) and 12 patients with non-POSA with a total median AHI of 23 (min 5, max 93) completed the study protocol. The median AHI decreased from 23 to 7 (p < 0.001) and the median ODI from 21 to 6 (p < 0.001). The median time spent in the supine position decreased from 142 to <1 min (p < 0.0001) and the median time in the prone position increased from <1 to 330 min (p < 0.0001). In all, 17 of 27 patients (63%) were considered to be responders to prone positioning, 12 of 15 (80%) with POSA and 5 of 12 (42%) with non-POSA. Five patients did not complete the study protocol due to sleep time <4 h.

Autoinflation for treatment of persistent otitis media with effusion in children: a cross-over study with a 12-month follow-up.

OBJECTIVES: The aims of the present study were to evaluate the efficacy of and compliance with a new device for autoinflation in the treatment of persistent otitis media with effusion (OME) in young children. METHODS: Forty-five children with persistent OME with a bilateral type B or C2 tympanogram for at least three months and history of subjective hearing loss, waiting for grommet surgery, were randomised to a treatment and a control group. Twenty-three children aged between three and eight years started as the treatment group with the new device for autoinflation. Another 22 children, aged between two and eight years were included as controls. After a period of four weeks, a cross-over was performed. Both groups underwent otomicroscopy, tympanometry and audiometry at inclusion and after one and two months for the evaluation of treatment efficiency. The primary outcome measurements were improvement in middle-ear pressure and hearing thresholds at eight weeks. Both groups were then followed up for another 10 months. RESULTS: In the treatment group, the mean middle-ear pressure for both ears and the mean hearing thresholds for the best ear improved by 166 daPa (p<0.0001) and 6 dB (p<0.0001), respectively after four weeks, while in the control group, non-significant alterations were observed. After the cross-over of the control group to treatment, equivalent improvements in the mean middle-ear pressure and the mean hearing thresholds of 187 daPa (p<0.0001) and 7 dB (p<0.01), respectively were achieved also in this group. After treatment in both groups at eight weeks, four of 45 children were submitted to grommet surgery. During the long-term follow-up another five children were submitted to surgery due to recurrence of disease. All the children managed to perform the manoeuvre and no side-effects were detected. CONCLUSION: The device demonstrated efficiency in improving both middle-ear pressure and hearing thresholds in most children after four weeks of treatment. It might therefore be possible to consider this method of autoinflation in children with persistent OME during the watchful waiting period.

A new device for treatment of persistent otitis media with effusion.

OBJECTIVES: Most children suffer from otitis media with effusion (OME) before starting school. Insertion of grommets into the eardrum for treatment of OME is one of the most common operations performed in childhood. The efficiency and compliance of treatment with a new non-invasive device was evaluated in children with bilateral OME with disease duration of at least 3 months. METHODS: A device for autoinflation was developed to enable a combined modified Valsalva and Politzer maneuver. Ten children, aged 3-8 years (mean: 5 years and 2 months) with OME tested the device for estimation of its ability to ventilate the middle ear. Another thirty-one children, with persistent bilateral OME for at least three months, were divided into a treatment and a control group. Twenty-one children (42 ears), aged 2-7 year (mean: 4 years and 6 months), participated as the treatment group and ten patients (20 ears), aged 3-7 years (mean: 4 years and 5 months), were included as controls. Tympanometry and otomicroscopy were performed at inclusion and at the end of the study. RESULTS: In the treatment group the middle ear pressure was normalized in 52% and improved in 31% of the ears with 7 children (33%) achieving bilateral and 8 (38%) unilateral normalization. In the control group the middle ear pressure was normalized in 15%, improved in 15% and deteriorated in 10% of the ears with one child (10%) achieving bilateral and one child (10%) unilateral normalization. Statistically significant differences (p < 0.001) were observed in the pressure difference and the tympanometry type changes between the treatment and the control group. Otomicroscopic examination revealed that the number of ears judged as OME was reduced by 62% in the treatment group in comparison with 20% in the control group. All children managed to perform the maneuver and no side effects were neither reported nor detected. CONCLUSIONS: The device was efficient in ventilation of the middle ear with normalization or improvement of the negative middle ear pressure and otomicroscopic findings in young children with persistent OME.