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From the Sleep Disorders Division, Department of Neurology (B.A.M.), and Department of Biostatistics (L.W., Y.S.), Vanderbilt University School of Medicine, Nashville, TN; Department of Neurology (N.F.-S.), Cleveland Clinic, OH; Department of Neurology (B.V.V.), University of North Carolina–Chapel Hill; Department of Neurology (L.M.S., R.D.C.), University of Michigan Medical Center, Ann Arbor; and Michigan Institute for Clinical and Health Research (K.J.W.), University of Michigan, Ann Arbor.
Address correspondence and reprint requests to Dr. Beth A. Malow, Vanderbilt University, Department of Neurology, Medical Center North, Room A-0118, 1161 21st Avenue South, Nashville, TN 37232-2551 beth.malow{at}vanderbilt.edu
Objective: Small uncontrolled series suggest that treatment of obstructive sleep apnea (OSA) in patients with epilepsy may improve seizure control. Prior to conducting a definitive randomized controlled trial, we addressed critical design issues in a pilot study.
Methods: We identified a cohort of adult patients with medically refractory epilepsy and coexisting OSA, documented by polysomnography (PSG). After an 8-week baseline period, subjects with OSA were randomized to therapeutic or sham continuous positive airway pressure (CPAP) for 10 weeks. Subjects maintained seizure calendars and antiepileptic drug dosages were held constant.
Results: Sixty-eight subjects with suspected OSA were enrolled and 35 subjects randomized to therapeutic CPAP (22 subjects) or sham (13 subjects) CPAP. Male gender and an elevated sleep apnea questionnaire score were predictive of OSA on PSG. Nineteen subjects in the therapeutic group and all 13 subjects in the sham group completed the trial. Baseline apnea-hypopnea index (AHI) and CPAP adherence were comparable between groups. A significant reduction in AHI was observed in the therapeutic CPAP group as compared to the sham group. Subjects, study coordinators, and principal investigators were unable to predict treatment allocation.
Conclusions: This pilot study provided critical information related to study design and feasibility for planning a comprehensive trial to test the hypothesis that treating obstructive sleep apnea in patients with epilepsy improves seizure control.
Abbreviations: AEDs = antiepileptic drugs; AHI = apnea-hypopnea index; BMI = body mass index; CPAP = continuous positive airway pressure; OSA = obstructive sleep apnea; PSG = polysomnography.
Supplemental data at www.neurology.org
Supported by NINDS R01 NS42698 and the General Clinical Research Centers at University of Michigan (M01-RR00042), University of North Carolina-Chapel Hill (M01-RR00146), and Vanderbilt University (M01-RR00095). Respironics, Inc. provided continuous positive airway pressure equipment for the trial. No other support for the trial was provided by Respironics.
Disclosure: The authors report no disclosures.
Received November 11, 2007. Accepted in final form May 7, 2008.
This article has been cited by other articles:
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  Obstructive Sleep Apnea in Adults with Epilepsy Journal Watch Neurology, January 6, 2009; 2009(106): 4 - 4. [Full Text]
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