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

NCT ID: NCT02209363

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2022-12-31

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.

Conditions

Parkinson's Disease; Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Positive airway pressure (PAP)

Auto-adjusting positive airway pressure

Group Type: EXPERIMENTAL

auto-adjusting positive airway pressure

Intervention Type: DEVICE

nightly use for 6 months

nasal dilator strips

Sham treatment

Group Type: SHAM_COMPARATOR

Nasal dilator strips

Intervention Type: OTHER

nightly use for 6 months

Interventions

auto-adjusting positive airway pressure

nightly use for 6 months

Intervention Type: DEVICE

Nasal dilator strips

nightly use for 6 months

Intervention Type: OTHER

Other Intervention Names

auto-CPAP; APAP; auto-PAP; Breathe-right

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

American Thoracic Society

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Marta Kaminska

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta Kaminska, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Montreal Neurological Hospital and Institute

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 39945727 (View on PubMed)

Other Identifiers

4120

Identifier Type: -

Identifier Source: org_study_id