Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy

Parkinson's Disease Clinical Trial

— COPE-PAP  

Official title:

Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209363
• Other study ID #: 4120
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2022

Study information

• Verified date: March 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cognitive dysfunction (impaired memory, thinking, etc) frequently occurs in Parkinson's 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Parkinson's disease as perMDS criteria

• Evidence of cognitive dysfunction (clinical impression of mild cognitive impairment and MOCA <=27)

• Presence of OSA (apnea-hypopnea index RDI = 15/h) on screening diagnostic polysomnography (PSG)

• Stable regimen of anti-PD medication for 1 month prior

• Adequate knowledge of English or French for completion of study assessment.

Exclusion Criteria:

• Oxygen saturation <75% for >10% of the diagnostic polysomnography as this should lead to active PAP treatment

• Other major neurological disorder

• Unstable cardiac disease, uncontrolled hypertension, or diabetes

• Active cancer or other disorder with an expected survival < 6 months

• Active treatment of OSA (prior diagnosis of OSA will constitute an exclusion criterion only if the patient is currently being treated for the OSA)

• Significant vision or hearing impairment that could affect performance on neurocognitive assessment tasks.

• Latex allergy.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Parkinson Disease
• Parkinson's Disease
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• auto-adjusting positive airway pressure
nightly use for 6 months

Other:
• Nasal dilator strips
nightly use for 6 months

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Montreal Neurological Hospital and Institute	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	American Thoracic Society, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	REM sleep behaviour disorder	Severity and frequency of symptoms in last 3 months will be assessed.	3 months and 6 months
Primary	Change in global cognitive function	Montreal Cognitive Assessment (MoCA) - score range 0-30.	6 months
Secondary	Change in non-motor symptoms of Parkinson's disease	MDS-UPDRS part 1	3 months and 6 months
Secondary	Change in quality of life	PDQ-39	3 months and 6 months
Secondary	Change in specific domains of neurocognitive function	Detailed neurocognitive assessment including attention and working memory, executive function, language, memory and visuospatial function.	3 months and 6 months
Secondary	Change in global cognitive function	Montreal Cognitive Assessment (MoCA)	3 months