Dataset Information

Extrapulmonary effects of continuous airway pressure on patients with obstructive sleep apnoea: protocol for an overview of systematic reviews.

ABSTRACT:

Introduction

Obstructive sleep apnoea (OSA) is associated with both pulmonary and extrapulmonary consequences. Continuous positive airway pressure (CPAP) is an effective treatment for pulmonary symptoms. However, it is not clear if CPAP modifies extrapulmonary symptoms, especially in the long term. To date, several studies addressing this issue have been performed, but the evidence is scattered across different reviews that address each outcome separately. Therefore, we will conduct an overview to assess and summarise all systematic reviews on the extrapulmonary effects of this intervention in patients with OSA.

Methods

This is a protocol for a systematic overview of reviews that will follow the guidelines from the Cochrane Handbook of Systematic Reviews of Interventions and PRISMA-P. We will conduct comprehensive literature searches using MEDLINE, EMBASE, Cochrane, CINAHL, DARE and Epistemonikos. We will consider systematic reviews and meta-analyses of randomised controlled trials evaluating the extrapulmonary effects of CPAP on OSA. Two reviewers will independently screen articles for inclusion using criteria that are determined a priori, assessing the quality of included reviews and extracting relevant information. We will create matrices of evidence in the Epistemonikos database, including all systematic reviews addressing a similar question and all studies addressing the question in those reviews. We will try to explain why studies are not included in individual reviews using the inclusion criteria, and we will estimate the overlap between different reviews in the same matrix of evidence.

Ethics and dissemination

This review will be published in a peer-reviewed journal.

Trial registration number

CRD42014013036.

SUBMITTER: Labarca G

PROVIDER: S-EPMC5734478 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Publications

Extrapulmonary effects of continuous airway pressure on patients with obstructive sleep apnoea: protocol for an overview of systematic reviews.

Labarca Gonzalo G Ortega Francisco F Arenas Alex A Reyes Tomas T Rada Gabriel G Jorquera Jorge J

BMJ open 20170630 6

<h4>Introduction</h4>Obstructive sleep apnoea (OSA) is associated with both pulmonary and extrapulmonary consequences. Continuous positive airway pressure (CPAP) is an effective treatment for pulmonary symptoms. However, it is not clear if CPAP modifies extrapulmonary symptoms, especially in the long term. To date, several studies addressing this issue have been performed, but the evidence is scattered across different reviews that address each outcome separately. Therefore, we will conduct an o ...[more]

PMID: 28667213

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Project description: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.

Project description:IntroductionObstructive sleep apnoea (OSA) is common among older surgical patients, and delirium is a frequent and serious postoperative complication. Emerging evidence suggests that OSA increases the risk for postoperative delirium. We hypothesise that OSA is an independent risk factor for postoperative delirium, and that in patients with OSA, perioperative adherence to positive airway pressure (PAP) therapy decreases the incidence of postoperative delirium and its sequelae. The proposed retrospective cohort analysis study will use existing datasets to: (i) describe and compare the incidence of postoperative delirium in surgical patients based on OSA diagnosis and treatment with PAP; (ii) assess whether preoperatively untreated OSA is independently associated with postoperative delirium; and (iii) explore whether preoperatively untreated OSA is independently associated with worse postoperative quality of life (QoL). The findings of this study will inform on the potential utility and approach of an interventional trial aimed at preventing postoperative delirium in patients with diagnosed and undiagnosed OSA.Methods and analysisObservational data from existing electronic databases will be used, including over 100 000 surgical patients and ~10 000 intensive care unit (ICU) admissions. We will obtain the incidence of postoperative delirium in adults admitted postoperatively to the ICU who underwent structured preoperative assessment, including OSA diagnosis and screening. We will use doubly robust propensity score methods to assess whether untreated OSA independently predicts postoperative delirium. Using similar methodology, we will assess if untreated OSA independently predicts worse postoperative QoL.Ethics and disseminationThis study has been approved by the Human Research Protection Office at Washington University School of Medicine. We will publish the results in a peer-reviewed venue. Because the data are secondary and high risk for reidentification, we will not publicly share the data. Data will be destroyed after 1 year of completion of active Institutional Review Board (IRB) approved projects.

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

Extrapulmonary effects of continuous airway pressure on patients with obstructive sleep apnoea: protocol for an overview of systematic reviews.

Introduction

Methods

Ethics and dissemination

Trial registration number

Publications

Extrapulmonary effects of continuous airway pressure on patients with obstructive sleep apnoea: protocol for an overview of systematic reviews.

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