Effects of Treating Obstructive Sleep Apnea in Epilepsy
2 other identifiers
interventional
68
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2002
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 7, 2002
CompletedFirst Posted
Study publicly available on registry
October 8, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
May 3, 2011
CompletedJuly 21, 2016
July 1, 2016
5.8 years
October 7, 2002
November 18, 2009
July 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
10 weeks
Secondary Outcomes (2)
Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP
10 weeks
Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea
prior to randomization
Study Arms (2)
CPAP active comparator
ACTIVE COMPARATORcontinuous positive airway pressure (CPAP)
CPAP Placebo
PLACEBO COMPARATORPlacebo-CPAP
Interventions
a mask treatment for sleep apnea
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Related Publications (2)
Malow BA, Foldvary-Schaefer N, Vaughn BV, Selwa LM, Chervin RD, Weatherwax KJ, Wang L, Song Y. Treating obstructive sleep apnea in adults with epilepsy: a randomized pilot trial. Neurology. 2008 Aug 19;71(8):572-7. doi: 10.1212/01.wnl.0000323927.13250.54.
PMID: 18711110RESULTSelwa LM, Marzec ML, Chervin RD, Weatherwax KJ, Vaughn BV, Foldvary-Schaefer N, Wang L, Song Y, Malow BA. Sleep staging and respiratory events in refractory epilepsy patients: Is there a first night effect? Epilepsia. 2008 Dec;49(12):2063-8. doi: 10.1111/j.1528-1167.2008.01681.x. Epub 2008 May 29.
PMID: 18513353RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Being a pilot study with a relatively small sample size, we were unable to isolate the effects of specific medications or seizure types on the presence of sleep apnea.
Results Point of Contact
- Title
- Beth Malow/Principal Investigator
- Organization
- Vanderbilt University
Study Officials
- PRINCIPAL INVESTIGATOR
Beth Malow, M.D., M.S.
Vanderbilt University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
October 7, 2002
First Posted
October 8, 2002
Study Start
September 1, 2002
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
July 21, 2016
Results First Posted
May 3, 2011
Record last verified: 2016-07