Effects of Treating Obstructive Sleep Apnea in Epilepsy

Phase 2

Completed

• Conditions: Epilepsy; Sleep Apnea; Obstructive Sleep Apnea
• Interventions: Device: continuous positive airway pressure (CPAP); Device: Placebo-CPAP

• Registration Number: NCT00047463
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2002-10-07
• Study First Submitted QC: 2002-10-07
• Study First Posted: 2002-10-08
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-11-18
• Results First Submitted QC: 2011-03-31
• Results First Posted: 2011-05-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP active comparator	continuous positive airway pressure (CPAP)	continuous positive airway pressure (CPAP)
CPAP Placebo	Placebo-CPAP	Placebo-CPAP

Primary Outcome Measures

Name	Time	Method
CPAP Adherence/Tolerance as Measured by Proportion of Nights Used	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

Name	Time	Method
Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP	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
Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea	prior to randomization	The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization

Trial Locations

Locations (4)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States