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Effects of Treating Obstructive Sleep Apnea in Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047463
Recruitment Status : Completed
First Posted : October 8, 2002
Results First Posted : May 3, 2011
Last Update Posted : July 21, 2016
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Beth Ann Malow, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Epilepsy Sleep Apnea Obstructive Sleep Apnea Device: continuous positive airway pressure (CPAP) Device: Placebo-CPAP Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Treating Obstructive Sleep Apnea in Epilepsy
Study Start Date : September 2002
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: CPAP active comparator
continuous positive airway pressure (CPAP)
Device: continuous positive airway pressure (CPAP)
a mask treatment for sleep apnea

Placebo Comparator: CPAP Placebo
Device: Placebo-CPAP

Primary Outcome Measures :
  1. CPAP Adherence/Tolerance as Measured by Proportion of Nights Used [ Time Frame: 10 weeks ]
    This measure quantifies how well patients use their CPAP. The standard unit of measurement is proportion of nights that the CPAP is used by a participant (total nights used/total nights the device could have been used), averaged across all participants . Data were downloaded by a card placed in the CPAP machine reflecting use over the entire 10 weeks.

Secondary Outcome Measures :
  1. Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP [ Time Frame: 10 weeks ]
    Patients all received a CPAP machine which either delivered CPAP or provided the patient with placebo CPAP, which had the same sensation as receiving CPAP

  2. Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea [ Time Frame: prior to randomization ]
    The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00047463

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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Beth Malow, M.D., M.S. Vanderbilt University
Publications of Results:
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Responsible Party: Beth Ann Malow, Professor of Neurology, Vanderbilt University Identifier: NCT00047463    
Other Study ID Numbers: IRB030633
1R01NS042698-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2002    Key Record Dates
Results First Posted: May 3, 2011
Last Update Posted: July 21, 2016
Last Verified: July 2016
Keywords provided by Beth Ann Malow, Vanderbilt University:
sleep apnea
obstructive sleep apnea
continuous positive airway pressure
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases