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Effects of Treating Obstructive Sleep Apnea in Epilepsy Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Effects of Treating Obstructive Sleep Apnea in Epilepsy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Effects of Treating Obstructive Sleep Apnea in Epilepsy Clinical research trials and Effects of Treating Obstructive Sleep Apnea in Epilepsy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Effects of Treating Obstructive Sleep Apnea in Epilepsy. Effects of Treating Obstructive Sleep Apnea in Epilepsy Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Effects of Treating Obstructive Sleep Apnea in Epilepsy clinical trial. Subjects often receive the most expert healthcare possible for their Effects of Treating Obstructive Sleep Apnea in Epilepsy condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Effects of Treating Obstructive Sleep Apnea in Epilepsy  Effects of Treating Obstructive Sleep Apnea in Epilepsy
Effects of Treating Obstructive Sleep Apnea in Epilepsy
For Condition: Epilepsy,Sleep Apnea,Obstructive Sleep Apnea
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: The purpose of this trial is 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.
Details: 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 4 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
BethMalow, Principal Investigator, Vanderbilt University
University of North Carolina *Recruiting*
Chapel Hill, North Carolina,
United States
Recruiting Kevin Weatherwax 734-615-6254
Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio,
United States
Recruiting Kevin Weatherwax 734-615-6254
Vanderbilt University *Recruiting*
Nashville, Tennessee,
United States
Recruiting Lydia MacDonald 615-936-1646
University of Michigan *Recruiting*
Ann Arbor, Michigan,
United States
Recruiting Kevin Weatherwax 734-615-6254
Additional Information:
Study ID Numbers: R01NS42698;
Study Start Date: September 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047463
Other Sleep Apnea Studies:
1. Effects of Treating Obstructive Sleep Apnea in Epilepsy
Related Studies:
Other Sleep Apnea Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Effects of Treating Obstructive Sleep Apnea in Epilepsy
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