Effects of Treating Obstructive Sleep Apnea in Epilepsy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsy Sleep Apnea Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CPAP active comparator

continuous positive airway pressure (CPAP)

Group Type ACTIVE_COMPARATOR

continuous positive airway pressure (CPAP)

Intervention Type DEVICE

a mask treatment for sleep apnea

CPAP Placebo

Placebo-CPAP

Group Type PLACEBO_COMPARATOR

Placebo-CPAP

Intervention Type DEVICE

Placebo-CPAP

Interventions

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continuous positive airway pressure (CPAP)

a mask treatment for sleep apnea

Intervention Type DEVICE

Placebo-CPAP

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No