Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047463
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2002-10-07
Brief Title:
Effects of Treating Obstructive Sleep Apnea in Epilepsy
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Effects of Treating Obstructive Sleep Apnea in Epilepsy
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01NS042698-01A1 | NIH | None | httpsreporternihgovquickSearch1R01NS042698-01A1 |