Original ArticleSleep Apnea Treatment After Stroke (SATS) Trial: Is It Feasible?
Section snippets
Study Design
The Sleep Apnea Treatment After Stroke (SATS) Trial was a single-center pilot, prospective, randomized, sham-controlled trial of CPAP in stroke patients in which subjects, treating physicians, and outcome assessors were masked to intervention allocation. Subjects were enrolled between September 2004 and March 2010 from the inpatient neurology service at the University of Michigan. Adult subjects were eligible if they had sustained an ischemic stroke, based on accepted clinical criteria,10
Results
Out of 87 subjects, 74 completed sleep apnea screening (Fig 1). Four of the 40 subjects who initiated polysomnography (10%) could not tolerate the procedure and abandoned the study during the night. Only 1 subject had an AHI ≥5 with more central apneic episodes than obstructive apneic episodes. Twenty-four of the 40 (60%) had obstructive sleep apnea (OSA), defined as an AHI of ≥5 with more obstructive than central apneic episodes. Five subjects were excluded off protocol. In 1 of these
Discussion
This first-ever randomized, sham-controlled trial of CPAP in patients with recent stroke and sleep apnea shows that sham CPAP can be an effective placebo even during the challenging immediate aftermath of ischemic stroke. In this trial, sham CPAP was at least as tolerable and believable as active CPAP. However, this rigorously designed and documented pilot randomized controlled trial also highlights challenges that need to be addressed to ensure the success of a full-scale, definitive trial.
Acknowledgment
Special thanks to Karen C. Johnston, MD, MSc, Medical Monitor.
References (41)
- et al.
Early investigation and treatment of obstructive sleep apnoea after acute stroke
J Clin Neurosci
(2007) - et al.
Comparison of therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: A randomized prospective parallel trial
Lancet
(1999) - et al.
Effect of CPAP treatment on mood states in patients with sleep apnea
J Psychiatr Res
(1999) - et al.
Prevalence of sleep apnea in a population of adults with type 2 diabetes mellitus
Endocr Pract
(2007) - et al.
Improvement in nocturnal disordered breathing after first-ever ischemic stroke: Role of dysphagia
Chest
(2006) - et al.
Effect of upper airway obstruction in acute stroke on functional outcome at 6 months
Thorax
(2004) - et al.
Sleep-related breathing disorders and rehabilitation outcome of stroke patients: A prospective study
Am J Phys Med Rehabil
(2003) - et al.
Relationship of sleep apnea to functional capacity and length of hospitalization following stroke
Sleep
(2003) - et al.
Obstructive sleep apnea is a risk factor for death in patients with stroke: A 10-year follow-up
Arch Intern Med
(2008) - et al.
Ambulatory blood pressure after therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: A randomized parallel trial
Lancet
(2001)
Sham continuous positive airway pressure for placebo-controlled studies in sleep apnoea
Lancet
Diagnostic criteria and quality control of the registration of stroke events in the MONICA project
Acta Med Scand Suppl
The Sleep Disorders Questionnaire I: Creation and multivariate structure of SDQ
Sleep
A new method for measuring daytime sleepiness: The Epworth Sleepiness Scale
Sleep
The PHQ-9: Validity of a brief depression severity measure
J Gen Intern Med
The fatigue severity scale: Application to patients with multiple sclerosis and systemic lupus erythematosus
Arch Neurol
Modification of the Rankin Scale: Recovery of motor function after stroke
Stroke
Functional evaluation: The Barthel Index
MD State Med J
Improved reliability of the NIH Stroke Scale using video training
Stroke
Sleep-related breathing disorders in adults: Recommendations for syndrome definition and measurement techniques in clinical research
Sleep
Cited by (0)
Supported by National Institutes of Health Grant K23 NS051202 and National Center for Research Resources Grant M01-RR000042. The contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health or the National Center for Research Resources. Respironics Inc (now Philips) and Puritan Bennett (now Covidian) provided material support but had no role in the study design, analysis, or manuscript preparation.