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 totherapeutic 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.
RCT Entities:
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.
Authors: F Barbé; L R Mayoralas; J Duran; J F Masa; A Maimó; J M Montserrat; C Monasterio; M Bosch; A Ladaria; M Rubio; R Rubio; M Medinas; L Hernandez; S Vidal; N J Douglas; A G Agustí Journal: Ann Intern Med Date: 2001-06-05 Impact factor: 25.391
Authors: Clete A Kushida; Deborah A Nichols; Stuart F Quan; James L Goodwin; David P White; Daniel J Gottlieb; James K Walsh; Paula K Schweitzer; Christian Guilleminault; Richard D Simon; Eileen B Leary; Pamela R Hyde; Tyson H Holmes; Daniel A Bloch; Sylvan Green; Linda K McEvoy; Alan Gevins; William C Dement Journal: J Clin Sleep Med Date: 2006-07-15 Impact factor: 4.062
Authors: Devin L Brown; Craig S Anderson; Ronald D Chervin; Clete A Kushida; Daniel S Lewin; Beth A Malow; Susan Redline; Edward B Goldman Journal: J Clin Sleep Med Date: 2011-02-15 Impact factor: 4.062
Authors: Hala A Shaheen; Ann A Abd El-Kader; Amira M El Gohary; Neveen M El-Fayoumy; Lamia M Afifi Journal: Sleep Breath Date: 2011-09-09 Impact factor: 2.816