Natalie C Wheeler1,2, Jeffrey J Wing3, Louise M O'Brien4, Rebecca Hughes2, Teresa Jacobs2, Edward Claflin5, Ronald D Chervin1,4, Devin L Brown1,2. 1. University of Michigan Department of Neurology, Ann Arbor, Michigan. 2. University of Michigan Stroke Program, Ann Arbor, Michigan. 3. Grand Valley State University Department of Public Health, Grand Rapids, Michigan. 4. University of Michigan Sleep Disorders Center, Ann Arbor, Michigan. 5. University of Michigan Department of Physical Medicine and Rehabilitation, Ann Arbor, Michigan.
Abstract
STUDY OBJECTIVES: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. METHODS: 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 α = 0.05. RESULTS: 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). CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT01703663.
RCT Entities:
STUDY OBJECTIVES: 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 strokepatients. We assessed whether nasal expiratory positive airway pressure (EPAP), an alternative to CPAP, may be an effective option after acute stroke. METHODS: We conducted a randomized, controlled, two-period crossover study in which each acute ischemic strokepatient 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 α = 0.05. RESULTS: 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). CONCLUSIONS: This study suggests that EPAP is not an effective alternative to CPAP in acute strokepatients with OSA. Further work is needed to identify other more effective alternatives. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT01703663.
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