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Combination of obstructive sleep apnoea and insomnia treated by continuous positive airway pressure with the SensAwake pressure relief technology to assist sleep: a randomised cross-over trial protocol.

ABSTRACT: INTRODUCTION:Obstructive sleep apnoea (OSA) is a common sleep breathing disorder affecting up to 17% of the middle-aged population. Continuous positive airway pressure (CPAP) is the primary treatment for patients with OSA, but acceptance and adherence to therapy is suboptimal in specific subgroups particularly those with insomnia or poor sleep quality (40%-80% of patients with OSA). Pressure intolerance, particularly during periods of wakefulness, inhibiting sleep onset or return to sleep, is one reason for poor CPAP adherence. AutoCPAPs continually monitor airflow changes and only increase the pressure when the upper airway requires it. Reducing the pressure during wakefulness-sleep transition and wakefulness-after-sleep-onset (WASO) may improve therapy comfort and potentially adherence without compromising therapy efficacy. We hypothesise that SensAwake, a pressure relief function that reduces CPAP pressure on the transition from sleep to wakefulness and on WASO, may improve objective sleep quality. METHODS AND ANALYSIS:This is a multicentre, randomised double-blind crossover clinical trial on patients with both OSA and insomnia. Insomnia is defined as Insomnia Severity Index >15 at screening. Baseline data, including actigraphy, are collected for 1?week before randomisation (1:1) to either conventional AutoCPAP or AutoCPAP with SensAwake for 4 weeks. After an evaluation visit, patients are switched to the other treatment arm for a further 4 weeks. Allowing for 20% dropout, 48 patients are required. If applicable, repeated measures analysis of variance will be used to assess differences in WASO measured by actigraphy (primary outcome), other actigraphy measures, AutoCPAP compliance, subjective questionnaire scores (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Short-Form 12 Health Survey) and 24?hours blood pressure (secondary outcomes). ETHICS AND DISSEMINATION:The protocol was approved by the regional Ethics Committee (CPP Sud-Est-V, IRB N°6705) on 9 December 2015, is registered on ClincalTrials.gov (NCT02721329) and started in June 2016 with expected publication of primary outcome results in 2018. TRIAL REGISTRATION NUMBER:NCT0272132; Pre-results.

SUBMITTER: Pepin JL

PROVIDER: S-EPMC5665214 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Combination of obstructive sleep apnoea and insomnia treated by continuous positive airway pressure with the SensAwake pressure relief technology to assist sleep: a randomised cross-over trial protocol.

Pepin Jean Louis JL Gagnadoux Frédéric F Foote Alison A Vicars Rachel R Ogra Bhavi B Viot-Blanc Véronique V Benmerad Meriem M D'Ortho Marie-Pia MP Tamisier Renaud R

BMJ open 20171027 10

<h4>Introduction</h4>Obstructive sleep apnoea (OSA) is a common sleep breathing disorder affecting up to 17% of the middle-aged population. Continuous positive airway pressure (CPAP) is the primary treatment for patients with OSA, but acceptance and adherence to therapy is suboptimal in specific subgroups particularly those with insomnia or poor sleep quality (40%-80% of patients with OSA). Pressure intolerance, particularly during periods of wakefulness, inhibiting sleep onset or return to slee ...[more]

PMID: 29079603

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Project description:Background:Continuous positive airway pressure (CPAP) is an effective treatment for obstructive sleep apnoea (OSA), but an evaluation of CPAP adherence is rarely carried out among patients with acute coronary syndrome (ACS). The goals of the study are to analyse long-term adherence and identify the predictors of non-compliance with CPAP treatment for patients with non-sleepy OSA and ACS. Methods:This is an ancillary study of the ISAACC study, which is a multicentre, prospective, open-label, parallel, randomized, and controlled trial (NCT01335087) in patients with hospital admission for ACS. For the purpose of this study, only non-sleepy patients with moderate or severe OSA and randomized to receive CPAP treatment were analysed (n=357). Non-compliance was defined as CPAP dropout or average cumulative CPAP use of <4 hours/night. Multivariable logistic regression analysis was performed to identify predictors of CPAP adherence. Results:Adherence to treatment was 35.3% at 12 months. According to the unadjusted analysis, higher apnoea-hypopnea index (AHI) (P<0.001) and oxygen desaturation index (ODI) (P=0.001) were associated with a lower risk of non-compliance. Multivariable logistic regression analysis showed that high AHI (P=0.0051), high amounts of smoking pack-year (P=0.0170), and long intensive care unit (ICU) stays (P=0.0263) were associated with lower odds of non-compliance. It also showed a significant interaction between ACS history and age (P=0.0131), such that young patients with their first ACS showed significantly lower odds of CPAP non-compliance than patients with recurrent ACS and significantly lower odds of CPAP non-compliance were associated with ageing only in patients with recurrent ACS. Conclusions:Protective factors against non-compliance with CPAP treatment in non-sleepy patients with ACS were illness severity (high values of AHI or ICU stay length) or smoking amount. Patients with no previous history of ACS showed lower odds of CPAP non-compliance than patients with a recurrent ACS with younger age.

Dataset Information

Combination of obstructive sleep apnoea and insomnia treated by continuous positive airway pressure with the SensAwake pressure relief technology to assist sleep: a randomised cross-over trial protocol.

Publications

Combination of obstructive sleep apnoea and insomnia treated by continuous positive airway pressure with the SensAwake pressure relief technology to assist sleep: a randomised cross-over trial protocol.

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