Clinical trial NCT00047463: Effects of Treating Obstructive Sleep Apnea in Epilepsy
Official title: Effects of Treating Obstructive Sleep Apnea in Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Sleep Apnea
Obstructive Sleep Apnea
Keywords: epilepsy
sleep apnea
obstructive sleep apnea
continuous positive airway pressure
CPAP
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2002-10-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Primary outcomes:
measure: CPAP Adherence/Tolerance as Measured by Proportion of Nights Used
timeFrame: 10 weeks
Secondary outcomes:
measure: Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP
timeFrame: 10 weeks
measure: Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea
timeFrame: prior to randomization
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Beth Malow, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malow BA, Foldvary-Schaefer N, Vaughn BV, Selwa LM, Chervin RD, Weatherwax KJ, Wang L, Song Y. Treating obstructive sleep apnea in adults with epilepsy: a randomized pilot trial. Neurology. 2008 Aug 19;71(8):572-7. doi: 10.1212/01.wnl.0000323927.13250.54.
citation: Selwa LM, Marzec ML, Chervin RD, Weatherwax KJ, Vaughn BV, Foldvary-Schaefer N, Wang L, Song Y, Malow BA. Sleep staging and respiratory events in refractory epilepsy patients: Is there a first night effect? Epilepsia. 2008 Dec;49(12):2063-8. doi: 10.1111/j.1528-1167.2008.01681.x. Epub 2008 May 29.