Ignite Creation Date:
2024-05-06 @ 3:06 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02209363
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2014-07-31
Brief Title:
Cognition and Obstructive Sleep Apnea in Parkinsons Disease Effect of Positive Airway Pressure Therapy
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Cognition and Obstructive Sleep Apnea in Parkinsons Disease Effect of Positive Airway Pressure Therapy COPE-PAP Trial
Status:
COMPLETED
Status Verified Date:
2024-03
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:
COPE-PAP
Brief Summary:
Cognitive dysfunction impaired memory thinking etc frequently occurs in Parkinsons disease PD often progresses to dementia and profoundly affects quality of life Obstructive sleep apnea OSA is a common disorder in the general population that is treatable with positive airway pressure PAP therapy It is known to impair cognitive function but whether treatment improves cognitive function is less clear When already affected by a degenerative process like PD the brain might be more vulnerable to the effects of OSA and more responsive to OSA treatment To date OSA has not been recognized as a significant factor in PD In preliminary work in PD patients the investigators have found an association between OSA and poor cognition and cognitive improvement with PAP therapy The investigators now wish to more rigorously evaluate the effect of OSA treatment on cognitive function in PD in a randomized controlled trial The investigators primary objective is to assess in PD patients with OSA and cognitive deficit the effect of OSA treatment on global cognitive function The investigators will also assess other non-motor symptoms of PD quality of life and specific domains of neurocognitive function PD patients will be recruited from the McGill Movement Disorders Clinic and other Quebec Parkinson Network Centres Participants will need to have evidence of cognitive deficit and presence of OSA on screening diagnostic polysomnography sleep study Ninety subjects will be randomly assigned to PAP or nasal dilator strips Detailed neuropsychological testing and other measurements including quality of life will be done at baseline 3 months and 6 months At the end of the study period subjects will have polysomnography on their respective treatment to assess efficacy with respect to OSA treatment This study may demonstrate that a non-pharmacologic intervention has the potential to have a marked beneficial impact on cognitive function and quality of life in a significant proportion of PD patients
Detailed Description:
None
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