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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease; Obstructive Sleep Apnea
• Intervention / Treatment: Device: auto-adjusting positive airway pressure; Other: Nasal dilator strips

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Jewish General Hospital
    • Montreal, Quebec, Canada
      • McGill University Health Centre
    • Montreal, Quebec, Canada
      • Montreal Neurological Hospital and Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive airway pressure (PAP); Auto-adjusting positive airway pressure	Device: auto-adjusting positive airway pressure; nightly use for 6 months; Other Names: APAP; auto-CPAP; auto-PAP
Sham Comparator: nasal dilator strips; Sham treatment	Other: Nasal dilator strips; nightly use for 6 months; Other Names: Breathe-right

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in global cognitive function	Montreal Cognitive Assessment (MoCA) - score range 0-30.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in non-motor symptoms of Parkinson's disease	MDS-UPDRS part 1	3 months and 6 months
Change in quality of life	PDQ-39	3 months and 6 months
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
Change in global cognitive function	Montreal Cognitive Assessment (MoCA)	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
REM sleep behaviour disorder	Severity and frequency of symptoms in last 3 months will be assessed.	3 months and 6 months

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Canadian Institutes of Health Research (CIHR); American Thoracic Society
• Investigators: Principal Investigator: Marta Kaminska, MD, MSc, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimated): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: OSA; cognition; CPAP; Parkinson's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Parkinson Disease; Apnea
• Other Study ID Numbers: 4120