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Completed

NCT Number: NCT02209363

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish General Hospital, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

auto-adjusting positive airway pressure

Device

nightly use for 6 months

Other names: auto-CPAP, APAP, auto-PAP

Nasal Dilator Strips

Other

nightly use for 6 months

Other names: Breathe-right

Primary outcomes

  1. Change in global cognitive function

    Time frame: 6 months

    Montreal Cognitive Assessment (MoCA) - score range 0-30.

Secondary outcomes

  1. Change in non-motor symptoms of Parkinson's disease

    Time frame: 3 months and 6 months

    MDS-UPDRS part 1

  2. Change in quality of life

    Time frame: 3 months and 6 months

    PDQ-39

  3. Change in specific domains of neurocognitive function

    Time frame: 3 months and 6 months

    Detailed neurocognitive assessment including attention and working memory, executive function, language, memory and visuospatial function.

  4. Change in global cognitive function

    Time frame: 3 months

    Montreal Cognitive Assessment (MoCA)

Other outcomes

  1. REM sleep behaviour disorder

    Time frame: 3 months and 6 months

    Severity and frequency of symptoms in last 3 months will be assessed.

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • American Thoracic Society
  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: COPE-PAP

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2014
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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