Effects of Treating Obstructive Sleep Apnea in Epilepsy - Full Text View

Sponsor:	Vanderbilt University
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00047463

Purpose

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.

Condition	Intervention	Phase
Epilepsy Sleep Apnea Obstructive Sleep Apnea	Device: continuous positive airway pressure (CPAP) Device: Placebo-CPAP	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effects of Treating Obstructive Sleep Apnea in Epilepsy

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Sleep Apnea

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

CPAP Adherence/Tolerance as Measured by Proportion of Nights [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
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. Data were downloaded by a card placed in the CPAP machine reflecting use over the entire 10 weeks.

Secondary Outcome Measures:

Ability to Blind CPAP [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Need for One vs. Two Nights of Baseline Sleep Studies [ Time Frame: 1 night ] [ Designated as safety issue: No ]
Ability to Screen for Sleep Apnea With a Questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	September 2002
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 continuous positive airway pressure (CPAP)	Device: continuous positive airway pressure (CPAP) a mask treatment for sleep apnea
Placebo Comparator: 2 Placebo-CPAP	Device: Placebo-CPAP Placebo-CPAP

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047463

Locations

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:

Beth Malow, M.D., M.S.

Vanderbilt University

More Information

Publications:

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.

Selwa 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. Epub 2008 May 29.

Responsible Party:	Beth Malow/Professor of Neurology, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00047463 History of Changes
Other Study ID Numbers:	IRB030633, R01NS42698
Study First Received:	October 7, 2002
Results First Received:	November 18, 2009
Last Updated:	March 31, 2011
Health Authority:	United States: Federal Government

Keywords provided by Vanderbilt University:

epilepsy
sleep apnea
obstructive sleep apnea
continuous positive airway pressure
CPAP

Additional relevant MeSH terms:

Apnea
Epilepsy
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders

ClinicalTrials.gov processed this record on February 12, 2012