Feasibility of home initiation of an airway clearance device (SIMEOX) by telecare in people with non-cystic fibrosis bronchiectasis: a pilot study.

BACKGROUND: Mucociliary clearance is a cornerstone of the management of people with non-cystic fibrosis bronchiectasis (NCFB). SIMEOX, an innovative device, could facilitate autonomous airway clearance, but its use requires specific training. We hypothesised that telecare would be an effective means to train people with NCFB in the handling of device and to monitor and promote device adherence. OBJECTIVES: (1) To evaluate frequency of use of the SIMEOX for 10 weeks after telecare training. (2) To assess user satisfaction and clinical efficacy of the SIMEOX+telecare. METHODS: Multicentre, prospective, pilot study in adults with NCFB. A SIMEOX was provided to each participant at inclusion. Physiotherapists performed telecare sessions the first 2 weeks (3-5 sessions) for device training and every 10 days to reinforce motivation and provide technical support. RESULTS: 22 individuals were included, 21 analysed (38% male; mean±SD age 53±18 years; Bronchiectasis Severity Index 6.6±3.5). Fourteen participants (66.7%; 95% CI 43.1% to 84.5%) performed ≥3 SIMEOX sessions/week (self-reported adherence, primary outcome). Median (Q1; Q3) number of self-reported sessions/week for the whole group was 3.7 (1.8; 5.7). Adherence including web registration was 80.9%. At week 12, participant satisfaction rating was 9.0 (7.9; 10.0) on a 10-point visual analogue scale; respiratory function did not change but quality of life improved (COPD Assessment Test score -4.7, 95% CI -7.7 to -1.6, p=0.023; St Georges Respiratory Questionnaire -5.8, 95% CI -10.8 to -0.9, p=0.005). CONCLUSION: Adherence to and satisfaction with the SIMEOX airway clearance device supported by telecare were high in people with NCFB. The clinical efficacy needs to be confirmed in a randomised controlled trial. TRIAL REGISTRATION NUMBER: NCT04742270.

Co-Design of a Voice-Based Digital Health Solution to Monitor Persisting Symptoms Related to COVID-19 (UpcomingVoice Study): Protocol for a Mixed Methods Study.

BACKGROUND: Between 10% and 20% of people with a COVID-19 infection will develop the so-called long COVID syndrome, which is characterized by fluctuating symptoms. Long COVID has a high impact on the quality of life of affected people, who often feel abandoned by the health care system and are demanding new tools to help them manage their symptoms. New digital monitoring solutions could allow them to visualize the evolution of their symptoms and could be tools to communicate with health care professionals (HCPs). The use of voice and vocal biomarkers could facilitate the accurate and objective monitoring of persisting and fluctuating symptoms. However, to assess the needs and ensure acceptance of this innovative approach by its potential users-people with persisting COVID-19-related symptoms, with or without a long COVID diagnosis, and HCPs involved in long COVID care-it is crucial to include them in the entire development process. OBJECTIVE: In the UpcomingVoice study, we aimed to define the most relevant aspects of daily life that people with long COVID would like to be improved, assess how the use of voice and vocal biomarkers could be a potential solution to help them, and determine the general specifications and specific items of a digital health solution to monitor long COVID symptoms using vocal biomarkers with its end users. METHODS: UpcomingVoice is a cross-sectional mixed methods study and consists of a quantitative web-based survey followed by a qualitative phase based on semistructured individual interviews and focus groups. People with long COVID and HCPs in charge of patients with long COVID will be invited to participate in this fully web-based study. The quantitative data collected from the survey will be analyzed using descriptive statistics. Qualitative data from the individual interviews and the focus groups will be transcribed and analyzed using a thematic analysis approach. RESULTS: The study was approved by the National Research Ethics Committee of Luxembourg (number 202208/04) in August 2022 and started in October 2022 with the launch of the web-based survey. Data collection will be completed in September 2023, and the results will be published in 2024. CONCLUSIONS: This mixed methods study will identify the needs of people affected by long COVID in their daily lives and describe the main symptoms or problems that would need to be monitored and improved. We will determine how using voice and vocal biomarkers could meet these needs and codevelop a tailored voice-based digital health solution with its future end users. This project will contribute to improving the quality of life and care of people with long COVID. The potential transferability to other diseases will be explored, which will contribute to the deployment of vocal biomarkers in general. TRIAL REGISTRATION: ClinicalTrials.gov NCT05546918; https://clinicaltrials.gov/ct2/show/NCT05546918. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46103.

Efficacy of the Simeox® Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial.

BACKGROUND: Cystic fibrosis (CF) patients require regular airway clearance therapy (ACT). The aim of this study was to evaluate homecare therapeutic effects of a new ACT (Simeox®) added to the optimal standard of care, including home chest physiotherapy, in the treatment of clinically stable children. METHODS: Forty pediatric CF patients (8-17 years old) with stable disease were randomized 1:1 in a single-center, prospective, open-label, cross-over trial into two groups: with or without Simeox®. Lung function (impulse oscillometry, spirometry, body plethysmography, multi-breath nitrogen washout) results, health-related quality of life, and safety were assessed during the study after 1 month of therapy at home. RESULTS: A significant decrease in proximal airway obstruction (as supported by improvement in airway resistance at 20 Hz (R20Hz) and maximum expiratory flow at 75% of FVC (MEF75)) compared to the control group was observed after 1 month of therapy with the device. Lung-clearance index was stable in the study group, while it worsened in the control group. In addition, the device group demonstrated a significant increase in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) physical score. No side effects were identified during the study. CONCLUSIONS: Simeox® may improve drainage of the airways in children with clinically stable CF and could be an option in chronic treatment of the disease.

Efficacy and tolerability of a custom-made Narval mandibular repositioning device for the treatment of obstructive sleep apnea: ORCADES study 2-year follow-up data.

OBJECTIVE/BACKGROUND: Mandibular repositioning device (MRD) therapy is an alternative to continuous positive airway pressure (CPAP). The Orkney Complex Disease Study-ORCADES study is assessing the long-term efficacy and tolerability of MRD therapy in obstructive sleep apnoea syndrome (OSAS); two-year follow-up data are presented. PATIENTS/METHODS: OSAS patients who refused or were noncompliant with CPAP were fitted with a custom-made computer-aided design/computer-aided manufacturing (CAD/CAM) bi-block MRD (ResMed, Narval CC™); mandibular advancement was individually titrated. Sleep and respiratory parameters were determined at baseline, 3-6 months, and two years. The primary endpoint was treatment success (percentage of patients achieving a ≥50% reduction in the apnoea-hypopnoea index [AHI]). RESULTS: Of 315 enrolled patients, 237 remained on MRD treatment at two years, and 197 had follow-up data. The treatment success rate at two years was 67%; AHI <5/h, <10/h and <15/h was achieved in 30%, 56% and 72% of patients, respectively. On multivariate analysis, ≥50% decrease in AHI at 3-6 months and absence of nocturia at 3-6 months were significant predictors of MRD treatment continuation. Adverse events were generally mild, and the majority occurred in the first year of treatment. CONCLUSIONS: Two years' treatment with an MRD was effective and well tolerated in patients with mild to severe OSAS who refused or were intolerant of CPAP.

Sex differences in mandibular repositioning device therapy effectiveness in patients with obstructive sleep apnea syndrome.

PURPOSE: Mandibular repositioning devices (MRDs) are an effective treatment option for obstructive sleep apnea syndrome (OSAS), particularly in patients who refuse or cannot tolerate continuous positive airway pressure (CPAP). However, sex differences in the response to therapy and predictors of response are not clearly defined. This analysis of data from the long-term prospective ORCADES trial compared MRD efficacy in men and women with OSAS. METHODS: The ORCADES study included patients with newly diagnosed mild-to-moderate or severe OSAS who refused or were non-compliant with CPAP. MRD therapy was titrated over 3-6 months. The primary endpoint was treatment success (≥ 50% decrease in apnea-hypopnea index (AHI)). Complete response was defined using a range of AHI cut-off values (< 5/h, < 10/h, < 15/h). RESULTS: Overall treatment success rates were 89% in women and 76% in men (p = 0.019); corresponding rates in those with severe OSAS (AHI > 30/h) were 100% and 68% (p = 0.0015). In women vs. men, overall complete response rates at AHI cut-off values of < 5/h, <10/h, and < 15/h were 49 vs. 34% (p = 0.0052), 78 vs. 62% (p = 0.016), and 92 vs. 76% (p = 0.0032). On multivariate analysis, significant predictors of MRD treatment success were overbite and baseline apnea index in men, and neck circumference and no previous CPAP therapy in women. There were sex differences in the occurrence of side effects. Temporomandibular joint pain was the most common reason for stopping MRD therapy. CONCLUSIONS: MRD therapy was effective in women with OSA of any severity, with significantly higher response rates compared with men especially in severe OSAS. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT01326143).

Rehabilitation Interventions to Promote Recovery from Schizophrenia: A Systematic Review.

Only one out of seven patients recovers after a first episode of psychosis despite psychiatric care. Rehabilitation interventions have been developed to improve functional outcomes and to promote recovery. We conducted a systematic review of the effectiveness of the main psychiatric rehabilitation interventions following a search of the electronic databases Pubmed, ScienceDirect, and Google Scholar using combinations of terms relating to cognitive remediation, psychoeducation, cognitive-behavioral therapies, and schizophrenia. Eighty articles relevant to the topic of interest were found. According to results, cognitive remediation has been found to be effective in reducing the impact of cognitive impairment, social skills in the learning a variety of skills and to a lesser extent in reducing negative symptoms, psychoeducation in improving compliance and reducing relapses, and cognitive therapy in reducing the intensity of or distress related to positive symptoms. All psychosocial rehabilitation interventions should be considered as evidence-based practices for schizophrenia and need to become a major part of the standard treatment of the disease.

Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial.

INTRODUCTION: Patient interface is important for the success of continuous positive airway pressure (CPAP), but few trials have examined the influence of mask choice on CPAP adherence. OBJECTIVES: To compare the impact of different nasal masks on CPAP in patients with newly-diagnosed obstructive sleep apnea (OSA). METHODS: OSA patients were randomized in a 2:3 ratio to receive CPAP via different first-line nasal masks: ResMed Mirage FX® (MFX) or control mask (Fisher & Paykel Zest® , HC407® or Philips EasyLife® ). Mask acceptance, CPAP compliance and Home Care Provider (HCP) interventions were compared between groups after 3 months of CPAP therapy using modified intent-to-treat (mITT; after exclusion of patients with mouth leaks during CPAP initiation) and on-treatment (OT; CPAP adherent) analyses. RESULTS: Of 285 randomized patients, 90 requiring a full-face mask were excluded, leaving 195 and 151 in the mITT and OT analyses, respectively. Mask acceptance rate was higher in the MFX versus control group (mITT: 79% vs 68%, P = 0.067; OT: 90% vs 76%, P = 0.022). CPAP compliance was higher (5.9 ± 1.8 vs 5.1 ± 1.6 h/night, P = 0.011) and nasal mask issue-related HCP visits lower (3% vs 17%, P = 0.006) in the MFX group. Nasal mask failures due to mask discomfort (5% vs 1%) or unintentional leakage (5% vs 0%) were higher in control vs MFX group. Mask acceptance was significantly associated with fewer mask leaks (P = 0.002) and higher pressure therapy (P = 0.042). CONCLUSIONS: This study highlights differences between nasal masks for CPAP delivery and shows that initial mask selection can influence adherence and healthcare utilization during CPAP.

Predictors of long-term effectiveness to mandibular repositioning device treatment in obstructive sleep apnea patients after 1000 days.

OBJECTIVE/BACKGROUND: In obstructive sleep apnea (OSA), long-term adherence to treatment is crucial. This prospective single-center study investigated factors associated with long-term adherence to mandibular repositioning device (MRD) therapy. PATIENTS/METHODS: All OSA patients who had MRD treatment initiated in the previous year were prospectively contacted to evaluate long-term effectiveness and compliance. Long-term adherence was based on continuation of treatment (yes/no). Predictors of long-term adherence were analyzed using an adjusted multivariate analysis. RESULTS: Median follow-up was 1002 days (interquartile range: 668-1345) in 279 patients (age 58 [50-64] years); 63% of patients were continuing MRD treatment with a good efficacy, tolerability and compliance over time. In some patients, relapse of nocturia was observed while efficacy was maintained for snoring and somnolence. In adjusted multivariate analysis, significant predictors of continuing MRD treatment were early ≥50% reduction in AHI (odds ratio [OR] 2.73, 95% confidence interval [CI] 1.466-5.10; p = 0.0002) and complete symptom resolution (OR 3.83, 95% CI 1.74-8.48; p = 0.0014). In the 37% of patients who stopped MRD treatment, median treatment duration was 351 (174-752) days. The main reasons for late stopping of treatment were inefficacy (26.2%), discomfort (25.2%) and side effects (21.4%). CONCLUSIONS: After three years, MRD was effective for the two-thirds of OSA patients who continued treatment. Relapse of nocturia might be an early signal of MRD wear that may explain long-term cessation of treatment in some patients. Short-term control of OSA by MAD was predictive of long-term efficiency. The major criteria were a ≥50% reduction in AHI and complete symptom resolution at short-term evaluation.

A custom-made mandibular repositioning device for obstructive sleep apnoea-hypopnoea syndrome: the ORCADES study.

BACKGROUND: Mandibular repositioning devices (MRDs) are usually recommended as the first therapy option in patients with mild-to-moderate obstructive sleep apnoea (OSA). However, data on the long-term efficacy of MRDs are limited, not only in OSA patients who are noncompliant with continuous positive airway pressure (CPAP) but also in those with more severe OSA. The ORCADES study aimed to prospectively determine the long-term efficacy and tolerability of two custom-made Narval(™) MRDs for obstructive sleep apnoea-hypopnoea syndrome (OSAHS) patients. The interim 3- to 6-month data are reported. METHODS: Eligible patients had OSAHS and had refused or were noncompliant with prescribed CPAP. Outcome measurements after gradual mandibular advancement titration included: apnoea-hypopnoea index (AHI), oxygen saturation, sleepiness, symptoms, quality of life, side effects and compliance. RESULTS: A total of 369 patients were included. Overall, MRD treatment was successful (≥50% decrease in AHI) in 76.2% of the participants; complete response (AHI <10/h) was achieved in 63.5%. Severe OSAHS was effectively treated (AHI <15/h) in about 60% of the participants; 38% had complete symptom resolution. Mandibular repositioning devices significantly decreased subjective sleepiness, eliminated symptoms and improved quality of life. They were well tolerated and compliance was excellent. Only 8% of the participants stopped MRD treatment due to side effects. CONCLUSION: Custom-made Narval(™) MRDs are effective for mild to severe OSA in patients who refuse or are noncompliant with CPAP. They are well tolerated and have excellent compliance.

Atrial fibrillation and sleep-disordered breathing.

Atrial fibrillation (AF) is a common supraventricular arrhythmia that increases in prevalence with increasing age and in the presence of comorbidities such as heart failure (HF). AF increases the risk of a number of serious complications, including stroke and HF. As a result, the rate of hospitalization is high, making AF a costly disease. Treatment strategies for AF are broadly based around rate and rhythm control, either pharmacological or mechanical. There appear to be a number of links between sleep-disordered breathing (SDB) and AF, although further studies are needed to fully understand the physiological mechanisms that link these conditions. Patients with AF and SDB share a number of risk factors and comorbidities, including age, male sex, hypertension, congestive HF and coronary artery disease (CAD), and the prevalence of SDB in AF is higher than in the general population. Prevalence rates of obstructive sleep apnea (OSA) in patients with AF have been reported to range from 21% to just over 80%. The prevalence of central sleep apnea (CSA) in patients with AF is less well defined, but appears to be particularly high in patients who also have HF and a reduced left ventricular ejection fraction (LVEF). The frequency of apneas can be reduced by effective treatment of AF, while co-existing OSA reduces the effectiveness of treatments for AF and there is an increased risk of arrhythmia recurrence in the presence of SDB. Treating OSA with continuous positive airway pressure (CPAP) therapy has shown the potential to decrease the incidence of AF, improve the effectiveness of AF interventions, and decrease the risk of arrhythmia recurrence, although data from large randomized, controlled clinical trials are lacking. Based on available data, inclusion of SDB recognition and management strategies as part of AF management appears to have the potential to reduce the impact of this arrhythmia at both the individual and societal levels, and has been recognized as important in recent guidelines.