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

NCT02209363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2024-03-13

No results posted yet for this study

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

Interventions

DEVICE

auto-adjusting positive airway pressure

nightly use for 6 months

OTHER

Nasal dilator strips

nightly use for 6 months

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • American Thoracic Society

    collaborator OTHER
  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Marta Kaminska, MD, MSc · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02209363 on ClinicalTrials.gov