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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
a mask treatment for sleep apnea
Placebo-CPAP
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
CPAP Adherence/Tolerance as Measured by Proportion of Nights Used
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.
Time frame: 10 weeks
Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP
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
Time frame: 10 weeks
Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea
The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization
Time frame: prior to randomization
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