Effects of Treating Obstructive Sleep Apnea in Epilepsy

Despite appropriate treatment with medications, individuals with epilepsy often continue to
have seizures, and many suffer from excessive daytime sleepiness and poor quality of life.
Evidence from case studies suggests that treatment of coexisting obstructive sleep apnea
(OSA)-stoppage in breathing during sleep-can reduce the frequency of seizures in people with
epilepsy that is resistant to antiepileptic medication.

In this study, individuals with symptoms of OSA and 2 or more seizures a month who meet
study criteria will undergo polysomnography, a test that continuously monitors normal and
abnormal physiological activity during sleep. Those individuals who test positive for OSA
will be randomized to either therapeutic or placebo continuous positive airway pressure
(CPAP)-a mask treatment for sleep apnea-for 10 weeks, during which time seizure frequency,
daytime sleepiness, health-related quality of life, and CPAP compliance will be assessed.

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.