Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease (TAP)
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|ClinicalTrials.gov Identifier: NCT00492115|
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : June 4, 2018
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Sleep Disordered Breathing||Device: Continuous positive airway pressure (CPAP) Device: Placebo CPAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Cognitive Benefits of Treating Sleep Apnea in Dementia|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Active Comparator: therapeutic CPAP Treatment (6 weeks)"
Intervention - The active comparator is an intervention of nightly therapeutic CPAP (continuous positive airway pressure) treatment for 6 weeks. Patients will use CPAP every night for the full duration of the study, i.e., 6 weeks
Device: Continuous positive airway pressure (CPAP)
therapeutic Continuous positive airway pressure (tCPAP) nightly for 6 weeks
Placebo Comparator: Sham CPAP/therapetuic CPAP (6 weeks)"
The placebo comparator is an intervention of placebo CPAP (continuous positive airway pressure) nightly for 3 weeks followed by therapeutic CPAP treatment nightly for 3 weeks.
Patients will use a sham CPAP (no real pressure) for 3 weeks and then will be switched to real CPAP for 3 weeks.
Device: Placebo CPAP
Ineffective Continuous positive airway pressure (pCPAP) for 3 weeks followed by therapeutic CPAP for 3 weeks
- Tests to Determine the Apnea-hypopnea Index (Number of Apneas and Hypopneas Per Hour of Sleep) [ Time Frame: six weeks ]Overnight sleep studies were done to determine the effect of treatment on the apnea-hypopnea index (number of apneas and hypopneas per hour of sleep)
- Sleep Stages; %Time Spent at SaO2<90%; [ Time Frame: 6 weeks ]Overnight sleep studies were done to examine the effect of CPAP treatment on sleep stages and on %time spent at Sa)2<90%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492115
|United States, California|
|San Diego, California, United States, 92093|
|Principal Investigator:||Sonia Ancoli-Israel, PhD||University of California, San Diego|