NCT00047463

Effects of Treating Obstructive Sleep Apnea in Epilepsy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy
• Sleep Apnea
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	continuous positive airway pressure (CPAP)	a mask treatment for sleep apnea
DEVICE	Placebo-CPAP	Placebo-CPAP

Timeline

• Start date: 2002-09-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2002-10-08
• Last updated: 2016-07-21
• Results posted: 2011-05-03

Locations

4 sites across 1 country: United States