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Effects of Treating Obstructive Sleep Apnea in Epilepsy

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00047463
First received: October 7, 2002
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
Results First Received: November 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Epilepsy
Sleep Apnea
Obstructive Sleep Apnea
Interventions: Device: continuous positive airway pressure (CPAP)
Device: Placebo-CPAP

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This pilot clinical trial was conducted between September 2002 and July 2005 at University of Michigan, Cleveland Clinic, University of North Carolina at Chapel Hill, and Vanderbilt University, with a Data Coordinating Center at the University of Michigan. 68 participants were enrolled and 35 were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Epilepsy clinic patients initially meeting trial eligibility on the basis of chart review completed the Sleep Apnea Scale of the Sleep Disorders Questionnaire, a validated instrument that assesses the likelihood of having obstructive sleep apnea, and underwent a sleep and epilepsy evaluation by the site investigator.

Reporting Groups
  Description
Placebo Continuous Positive Airway Pressure With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
Continuous Positive Airway Pressure Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.

Participant Flow:   Overall Study
    Placebo Continuous Positive Airway Pressure     Continuous Positive Airway Pressure  
STARTED     13     22  
Treatment Phase     13     22  
COMPLETED     13     19  
NOT COMPLETED     0     3  
Withdrawal by Subject                 0                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Continuous Positive Airway Pressure With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
Continuous Positive Airway Pressure Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
Total Total of all reporting groups

Baseline Measures
    Placebo Continuous Positive Airway Pressure     Continuous Positive Airway Pressure     Total  
Number of Participants  
[units: participants]
 		  13     22     35  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     13     22     35  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  40.2  ± 14.3     42.7  ± 12.3     41.8  ± 12.9  
Gender  
[units: participants]
 		     
Female     7     8     15  
Male     6     14     20  
Region of Enrollment  
[units: participants]
 		     
United States     13     22     35  



  Outcome Measures

1.  Primary:   CPAP Adherence/Tolerance as Measured by Proportion of Nights   [ Time Frame: 10 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Ability to Blind CPAP   [ Time Frame: 10 weeks ]
Results not yet posted.   Anticipated Posting Date:   10/2011   Safety Issue:   No

3.  Secondary:   Need for One vs. Two Nights of Baseline Sleep Studies   [ Time Frame: 1 night ]
Results not yet posted.   Anticipated Posting Date:   10/2011   Safety Issue:   No

4.  Secondary:   Ability to Screen for Sleep Apnea With a Questionnaire   [ Time Frame: 1 day ]
Results not yet posted.   Anticipated Posting Date:   10/2011   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Beth Malow/Principal Investigator
Organization: Vanderbilt University
phone: 615-322-0283
e-mail: beth.malow@vanderbilt.edu


Publications of Results:


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