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Effects of Treating Obstructive Sleep Apnea in Epilepsy

Primary Purpose

Epilepsy, Sleep Apnea, Obstructive Sleep Apnea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
continuous positive airway pressure (CPAP)
Placebo-CPAP
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, sleep apnea, obstructive sleep apnea, continuous positive airway pressure, CPAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan
  • University of North Carolina
  • Cleveland Clinic Foundation
  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CPAP active comparator

CPAP Placebo

Arm Description

continuous positive airway pressure (CPAP)

Placebo-CPAP

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP
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
The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization

Full Information

First Posted
October 7, 2002
Last Updated
July 20, 2016
Sponsor
Vanderbilt University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00047463
Brief Title
Effects of Treating Obstructive Sleep Apnea in Epilepsy
Official Title
Effects of Treating Obstructive Sleep Apnea in Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Sleep Apnea, Obstructive Sleep Apnea
Keywords
epilepsy, sleep apnea, obstructive sleep apnea, continuous positive airway pressure, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP active comparator
Arm Type
Active Comparator
Arm Description
continuous positive airway pressure (CPAP)
Arm Title
CPAP Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-CPAP
Intervention Type
Device
Intervention Name(s)
continuous positive airway pressure (CPAP)
Intervention Description
a mask treatment for sleep apnea
Intervention Type
Device
Intervention Name(s)
Placebo-CPAP
Intervention Description
Placebo-CPAP
Primary Outcome Measure Information:
Title
CPAP Adherence/Tolerance as Measured by Proportion of Nights Used
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP
Description
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
Time Frame
10 weeks
Title
Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea
Description
The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization
Time Frame
prior to randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Malow, M.D., M.S.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18711110
Citation
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.
Results Reference
result
PubMed Identifier
18513353
Citation
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. doi: 10.1111/j.1528-1167.2008.01681.x. Epub 2008 May 29.
Results Reference
result

Learn more about this trial

Effects of Treating Obstructive Sleep Apnea in Epilepsy

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