The purpose of this trial is to determine whether treating sleep-related breathing disorders in people with epilepsy results in improvement in seizure control or an improvement in alertness during the day.

Condition	Treatment or Intervention	Phase
Epilepsy Sleep Apnea Obstructive Sleep Apnea	Device: continuous positive airway pressure (CPAP)	Phase II

Further Study Details: 

Expected Total Enrollment:  60

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 4 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Kevin Weatherwax      734-615-6254 

Michigan
      University of Michigan, Ann Arbor,  Michigan,  United States; Recruiting
North Carolina
      University of North Carolina, Chapel Hill,  North Carolina,  United States; Recruiting
Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  United States; Recruiting
Tennessee
      Vanderbilt University, Nashville,  Tennessee,  United States; Recruiting

Study chairs or principal investigators

Beth Malow, M.D., M.S.,  Principal Investigator,  Vanderbilt University   

Study ID Numbers:  R01NS42698
Record last reviewed:  October 2004
Last Updated:  October 16, 2004
Record first received:  October 7, 2002
ClinicalTrials.gov Identifier:  NCT00047463
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08