Parkinson's DiseaseCOPE-PAPNCT02209363
Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy
A study testing auto-adjusting positive airway pressure and Nasal dilator strips in people with Parkinson's Disease and Obstructive Sleep Apnea, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Obstructive Sleep Apnea
- What is being tested?
- auto-adjusting positive airway pressure and Nasal dilator strips
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2015to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Jewish General Hospital
Montreal, Quebec
McGill University Health Centre
Montreal, Quebec
Montreal Neurological Hospital and Institute
Montreal, Quebec
About this study
Official title: 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.
- Conditions
- Parkinson's Disease, Obstructive Sleep Apnea
- Being tested
- auto-adjusting positive airway pressure, Nasal dilator strips
- Keywords
- Parkinson's disease, OSA, CPAP, cognition
- Medical subject headings
- Parkinson Disease, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auto-adjusting positive airway pressureDevice
Also called auto-CPAP, APAP, auto-PAP
nightly use for 6 months
Nasal dilator stripsOther
Also called Breathe-right
nightly use for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Positive airway pressure (PAP) | Experimental | Auto-adjusting positive airway pressure Receives: Device: auto-adjusting positive airway pressure |
| nasal dilator strips | Sham comparator | Sham treatment Receives: Other: Nasal dilator strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global cognitive function
Montreal Cognitive Assessment (MoCA) - score range 0-30.
Measured: 6 months
Secondary outcomes (4)
Change in non-motor symptoms of Parkinson's disease
MDS-UPDRS part 1
Measured: 3 months and 6 months
Change in quality of life
PDQ-39
Measured: 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.
Measured: 3 months and 6 months
Change in global cognitive function
Montreal Cognitive Assessment (MoCA)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startApr 2015
- Primary completionJun 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), American Thoracic Society
- Responsible party
- Principal investigator, Marta Kaminska, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Marta Kaminska, MD, MSc, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209363
- Sponsor's protocol ID
- 4120
- Acronym
- COPE-PAP
- Status last verified
- Mar 2024
- First submitted
- 31 Jul 2014
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Lajoie AC, Lafontaine AL, Kimoff RJ, Benedetti A, Robinson AR, Letourneau M, Crane J, Scanga A, Noel F, Kaminska M. Cognition and obstructive sleep apnea in Parkinson's disease: randomized controlled trial of positive airway pressure. Sleep. 2025 Jul 11;48(7):zsaf038. doi: 10.1093/sleep/zsaf038.
PubMed 39945727
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP Trial)
- ClinicalTrials.gov ID
- NCT02209363
- Acronym / sponsor ID
- COPE-PAP / 4120
- Conditions
- Parkinson's Disease, Obstructive Sleep Apnea
- Keywords
- Parkinson's disease, OSA, CPAP, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), American Thoracic Society
- Study start
- Apr 2015
- Primary completion
- Jun 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive airway pressure (PAP) | Experimental | Device: auto-adjusting positive airway pressureAuto-adjusting positive airway pressure |
| nasal dilator strips | Sham comparator | Other: Nasal dilator stripsSham treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auto-adjusting positive airway pressureAlso: auto-CPAP, APAP, auto-PAPnightly use for 6 months | Device | Positive airway pressure (PAP) |
| Nasal dilator stripsAlso: Breathe-rightnightly use for 6 months | Other | nasal dilator strips |
Primary outcome
Change in global cognitive function
Time frame: 6 months
Montreal Cognitive Assessment (MoCA) - score range 0-30.
4 secondary outcomes
Change in non-motor symptoms of Parkinson's disease
Time frame: 3 months and 6 months
Change in quality of life
Time frame: 3 months and 6 months
Change in specific domains of neurocognitive function
Time frame: 3 months and 6 months
Change in global cognitive function
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 39945727Lajoie AC, Lafontaine AL, Kimoff RJ, Benedetti A, Robinson AR, Letourneau M, Crane J, Scanga A, Noel F, Kaminska M. Cognition and obstructive sleep apnea in Parkinson's disease: randomized controlled trial of positive airway pressure. Sleep. 2025 Jul 11;48(7):zsaf038. doi: 10.1093/sleep/zsaf038.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Kaminska, MD, MSc principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auto-adjusting positive airway pressure and Nasal dilator strips in people with Parkinson's Disease and Obstructive Sleep Apnea, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognitive function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02209363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.