Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492115
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2007-06-26
Brief Title:
Cognitive Benefits of Treating Sleep Apnea in Parkinsons Disease
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Cognitive Benefits of Treating Sleep Apnea in Dementia
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAP
Brief Summary:
Patients with sleep disordered breathing SDB also called sleep apnea experience nighttime disrupted sleep and because they stop breathing for short periods during the night do not get sufficient oxygen to their brains This can frequently result in daytime impairments including difficulties with memory The state-of-the-art treatment for SDB is Continuous Positive Airway Pressure CPAP Many non-demented SDB patients who are successfully treated with CPAP show improvement in memory and other cognitive functions Data have shown that patients with Parkinsons disease have a high rate of SDB Patients with Parkinsons disease also often have problems with memory This study will test the effects of treating SDB among patients with Parkinsons disease and SDB Specifically the study will test the effect of CPAP treatment on SDB and sleep the effect of CPAP treatment on daytime sleepiness cognition overall quality of life and mood the effect of CPAP treatment on the frequency of symptoms of REM behavior disorder and restless legs syndrome the effect of continued CPAP use beyond the six weeks of the study on SDB sleep cognition mood and quality of life whether the study-partner feels that CPAP improves the patients sleep mood and overall functioning whether study-partners feel that their own sleep mood and overall functioning improve as the patients sleep improves both during the 6-week protocol and at follow-up for those opting to continue using CPAP
Detailed Description:
This study will examine the effect of three weeks vs six weeks of CPAP treatment on cognitive functioning and sleep in patients with Parkinsons disease and sleep apnea It is designed as a randomized double blind placebo-controlled trial of CPAP As a comparison group half the patients will first be randomly assigned to three weeks of shamCPAP followed by three weeks of therapeutic CPAP treatment Sleep functional outcome and mood questionnaires and a repeatable neuropsychological test battery chosen to be sensitive to the type of changes we expect to find in memory and cognitive function will be administered before the start of treatment after three weeks and after six weeks of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG008415 | NIH | None | httpsreporternihgovquickSearchR01AG008415 |