Effects of Treating Obstructive Sleep Apnea in Epilepsy
Epilepsy, Sleep Apnea, Obstructive Sleep Apnea
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, sleep apnea, obstructive sleep apnea, continuous positive airway pressure, CPAP
Eligibility Criteria
Inclusion Criteria: Age of 18 years or older. A history supportive of obstructive sleep apnea. Subject is able and willing to provide informed consent and to cooperate with polysomnography. Four or more quantifiable seizures per month. Subjects and their physicians agree to have their medication regimens optimized so that they are on the best regimen titrated to therapeutic benefit prior to the baseline phase of the study. Exclusion Criteria: Seizures secondary to drugs, alcohol, infection, neoplasia, demyelination, metabolic illness, or progressive degenerative disease. Non-epileptic spells (e.g., pseudoseizures) alone or in combination with epileptic seizures. Narcolepsy or another primary sleep disorder that requires intervention with medications and which may affect results of study (e.g., severe periodic limb movement disorder). Effectively treated OSA or prior exposure to continuous positive airway pressure. History of poor compliance with antiepileptic medications. Current treatment with the vagus nerve stimulator. Pregnancy. A significant history of medical or psychiatric disease which may impair participation in the trial. A history of alcohol or drug abuse during the one-year period prior to trial participation. Evidence of medical instability (e.g., congestive heart failure, cardiac arrhythmias, pulmonary disease) due to obstructive sleep apnea. Subjects who are unaware of the majority of their seizures and lack a reliable witness. Greater than ten seizures a day.
Sites / Locations
- University of Michigan
- University of North Carolina
- Cleveland Clinic Foundation
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
CPAP active comparator
CPAP Placebo
continuous positive airway pressure (CPAP)
Placebo-CPAP