Effects of Treating Obstructive Sleep Apnea in Epilepsy

Completed · Phase 2 · Has a placebo group

Conditions studied: Epilepsy, Sleep Apnea, Obstructive Sleep Apnea

In brief

The purpose of this trial is to work out design issues prior to conducting a definitive phase 3 trial 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.

Key facts

Study ID

NCT00047463

Run by

Vanderbilt University

People needed

68

Starts

2002-09-01

Expected to finish

2008-07-01

Last updated by the study team

2016-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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