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OpenTrials
Completed

NCT Number: NCT00047463

Effects of Treating Obstructive Sleep Apnea in Epilepsy

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Device

a mask treatment for sleep apnea

Placebo-CPAP

Device

Placebo-CPAP

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Oct 8, 2002
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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