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Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial.

ABSTRACT: Obstructive sleep apnea (OSA) is common after stroke and predicts poor outcomes. Continuous positive airway pressure (CPAP) treats OSA but is generally poorly tolerated by stroke patients. We assessed whether nasal expiratory positive airway pressure (EPAP), an alternative to CPAP, may be an effective option after acute stroke.We conducted a randomized, controlled, two-period crossover study in which each acute ischemic stroke patient received 1 night of EPAP and 1 night without EPAP while OSA was monitored with a validated device, the Watch-PAT 200. Linear repeated- measures analyses were conducted. Sample size calculations indicated that 18 subjects would be required to detect a 10-point or larger average reduction in the apnea-hypopnea index (AHI, the primary outcome), with use of EPAP, with power ? 80% and ? = 0.05.Among the 19 subjects who completed the protocol, nasal EPAP treatment was associated with a nonsignificant absolute difference in AHI of -5.73 events/h in the primary analysis (p = 0.183, 95% confidence interval -14.4, 2.97) and a nonsignificant absolute difference in AHI of -5.43 events/h in the subgroup of patients who used nasal EPAP for ? 3 h (p = 0.314, 95% confidence interval -16.6, 5.76).This study suggests that EPAP is not an effective alternative to CPAP in acute stroke patients with OSA. Further work is needed to identify other more effective alternatives.ClinicalTrials.gov, ID: NCT01703663.

SUBMITTER: Wheeler NC

PROVIDER: S-EPMC4990945 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial.

Wheeler Natalie C NC Wing Jeffrey J JJ O'Brien Louise M LM Hughes Rebecca R Jacobs Teresa T Claflin Edward E Chervin Ronald D RD Brown Devin L DL

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine 20160915 9

<h4>Study objectives</h4>Obstructive sleep apnea (OSA) is common after stroke and predicts poor outcomes. Continuous positive airway pressure (CPAP) treats OSA but is generally poorly tolerated by stroke patients. We assessed whether nasal expiratory positive airway pressure (EPAP), an alternative to CPAP, may be an effective option after acute stroke.<h4>Methods</h4>We conducted a randomized, controlled, two-period crossover study in which each acute ischemic stroke patient received 1 night of ...[more]

PMID: 27306393

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Project description:STUDY OBJECTIVES:Obstructive sleep apnea (OSA) is an independent risk factor for stroke. The objective of this study was to assess the effect of continuous positive airway pressure (CPAP) treatment on prevention of new vascular events among patients with stroke and OSA. METHODS:Consecutive conscious patients presenting with first imaging-confirmed arterial stroke were included, 6 weeks or more after ictus. All patients underwent clinical and polysomnography (PSG) testing. Patients with an apnea-hypopnea index (AHI) of > 15 events/h were randomized to posttitration nightly CPAP treatment and non-CPAP (received best medical treatment) groups. On follow-up at 3, 6, and 12 months from randomization, evaluation was carried out for any new vascular events as the primary outcome measure, and for clinical stroke outcomes (using the Barthel Index and modified Rankin scale) and neuropsychological parameters as the secondary outcome measures. RESULTS:Among the 679 patients with stroke who were screened, 116 reported for PSG, 83 had AHI > 15 events/h, and 70 (34 in CPAP and 36 in non-CPAP) were randomized. Thirteen patients could not be randomized because of a lack of CPAP devices. Four patients crossed over from the CPAP to the non-CPAP group. Age (mean age 53.41 ± 9.85 in CPAP versus 52.69 ± 13.23 years in non-CPAP, P = .81) and sex distribution (24 males in CPAP versus 33 males in non-CPAP, P = .79) were similar in both groups. At 12-month follow-up, there was 1 vascular event (3.33%) in the CPAP group and 6 events (15%) in the non-CPAP group (P = .23). Modified Rankin scale score improvement by ? 1 at 12-month follow-up was found in significantly more patients in the CPAP group than in the non-CPAP group (53% versus 27%). CONCLUSIONS:These findings suggest significantly better stroke outcomes and statistically nonsignificant favorable outcomes in terms of recurrence of vascular events for patients with stroke and OSA who use CPAP treatment. CLINICAL TRIAL REGISTRATION:Registry: Clinical Trials Registry - India, CTRI Registration No: CTRI/2016/07.007104, Title: Sleep Disordered Breathing in stroke patients: Effect of treatment trial, URL: http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=8682&EncHid=&userName=sleep%20disordered%20breathing.

Project description:Obstructive sleep apnea (OSA) is a serious and costly public health problem. The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients. Upper airway reconstructive surgery is available when medical treatments fail but randomized trial evidence supporting its use is limited. This protocol details a randomized controlled trial designed to assess the clinical effectiveness, safety, and cost-effectiveness of a multilevel upper airway surgical procedure for OSA. A prospective, parallel-group, open label, randomized, controlled, multicenter clinical trial in adults with moderate or severe OSA who have failed or refused medical therapies. Six clinical sites in Australia randomly allocated participants in a 1:1 ratio to receive either an upper airway surgical procedure consisting of a modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction, or to continue with ongoing medical management, and followed them for 6 months. Primary outcomes: difference between groups in baseline-adjusted 6 month OSA severity (apnea-hypopnea index) and subjective sleepiness (Epworth Sleepiness Scale). Secondary outcomes: other OSA symptoms (e.g. snoring and objective sleepiness), other polysomnography parameters (e.g. arousal index and 4% oxygen desaturation index), quality of life, 24 hr ambulatory blood pressure, adverse events, and adherence to ongoing medical therapies (medical group). The Sleep Apnea Multilevel Surgery (SAMS) trial is of global public health importance for testing the effectiveness and safety of a multilevel surgical procedure for patients with OSA who have failed medical treatment. Multilevel airway surgery in patients with moderate-severe Obstructive Sleep Apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true Australian New Zealand Clinical Trials Registry ACTRN12614000338662, prospectively registered on 31 March 2014.

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Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial.

Publications

Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial.

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