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

Primary Purpose

Parkinson's Disease, Obstructive Sleep Apnea

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
auto-adjusting positive airway pressure
Nasal dilator strips
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, OSA, CPAP, cognition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Positive airway pressure (PAP)

nasal dilator strips

Arm Description

Auto-adjusting positive airway pressure

Sham treatment

Outcomes

Primary Outcome Measures

Change in global cognitive function
Montreal Cognitive Assessment (MoCA) - score range 0-30.

Secondary Outcome Measures

Change in non-motor symptoms of Parkinson's disease
MDS-UPDRS part 1
Change in quality of life
PDQ-39
Change in specific domains of neurocognitive function
Detailed neurocognitive assessment including attention and working memory, executive function, language, memory and visuospatial function.
Change in global cognitive function
Montreal Cognitive Assessment (MoCA)

Full Information

First Posted
July 31, 2014
Last Updated
August 22, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR), American Thoracic Society
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1. Study Identification

Unique Protocol Identification Number
NCT02209363
Brief Title
Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy
Acronym
COPE-PAP
Official Title
Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2022 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR), American Thoracic Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Obstructive Sleep Apnea
Keywords
Parkinson's disease, OSA, CPAP, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive airway pressure (PAP)
Arm Type
Experimental
Arm Description
Auto-adjusting positive airway pressure
Arm Title
nasal dilator strips
Arm Type
Sham Comparator
Arm Description
Sham treatment
Intervention Type
Device
Intervention Name(s)
auto-adjusting positive airway pressure
Other Intervention Name(s)
auto-CPAP, APAP, auto-PAP
Intervention Description
nightly use for 6 months
Intervention Type
Other
Intervention Name(s)
Nasal dilator strips
Other Intervention Name(s)
Breathe-right
Intervention Description
nightly use for 6 months
Primary Outcome Measure Information:
Title
Change in global cognitive function
Description
Montreal Cognitive Assessment (MoCA) - score range 0-30.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in non-motor symptoms of Parkinson's disease
Description
MDS-UPDRS part 1
Time Frame
3 months and 6 months
Title
Change in quality of life
Description
PDQ-39
Time Frame
3 months and 6 months
Title
Change in specific domains of neurocognitive function
Description
Detailed neurocognitive assessment including attention and working memory, executive function, language, memory and visuospatial function.
Time Frame
3 months and 6 months
Title
Change in global cognitive function
Description
Montreal Cognitive Assessment (MoCA)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
REM sleep behaviour disorder
Description
Severity and frequency of symptoms in last 3 months will be assessed.
Time Frame
3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Kaminska, MD, MSc
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal Neurological Hospital and Institute
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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

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