Effects of Treating Obstructive Sleep Apnea in Epilepsy

Epilepsy Clinical Trial

Official title:

Effects of Treating Obstructive Sleep Apnea in Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047463
• Other study ID #: IRB030633
• Secondary ID: 1R01NS042698-01A
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2002
• Last updated: July 20, 2016
• Start date: September 2002
• Est. completion date: July 2008

Study information

• Verified date: July 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Epilepsy
• Obstructive Sleep Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• continuous positive airway pressure (CPAP)
a mask treatment for sleep apnea
• Placebo-CPAP
Placebo-CPAP

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & 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. — View 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	10 weeks	No
Secondary	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	prior to randomization	No