Treating obstructive sleep apnea in adults with epilepsy: a randomized pilot trial.
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.
Malow
B A
BA
Vanderbilt University, Department of Neurology, Medical Center North, Room A-0118, 1161 21st Avenue South, Nashville, TN 37232-2551, USA. beth.malow@vanderbilt.edu
Foldvary-Schaefer
N
N
Vaughn
B V
BV
Selwa
L M
LM
Chervin
R D
RD
Weatherwax
K J
KJ
Wang
L
L
Song
Y
Y
D000328:Adult; D045422:Continuous Positive Airway Pressure / Q000295:instrumentation* / Q000379:methods; D004311:Double-Blind Method; D004827:Epilepsy / Q000150:complications* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010865:Pilot Projects; D017286:Polysomnography; D011446:Prospective Studies; D012720:Severity of Illness Index; D020181:Sleep Apnea, Obstructive / Q000150:complications* / Q000175:diagnosis / Q000628:therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome