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

  • STATUS
    Recruiting
  • End date
    Jun 7, 2022
  • participants needed
    90
  • sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
Updated on 7 March 2021
cognitive impairment
behavioral therapy
dementia
polysomnography
apnea-hypopnea index
motor symptoms
movement disorder

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.

Details
Condition Parkinson's disease, Obstructive sleep apnea, obstructive sleep apnoea, obstructive sleep apnea syndrome, parkinson's, parkinson disease
Treatment Nasal Dilator Strips, auto-adjusting positive airway pressure
Clinical Study IdentifierNCT02209363
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Last Modified on7 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Obstructive sleep apnea or Parkinson's disease?
Do you have any of these conditions: parkinson disease or obstructive sleep apnea syndrome or Obstructive sleep apnea or obstructive sleep apnoea or parkinson's or Parkinson's disease?
Do you have any of these conditions: Parkinson's disease or parkinson disease or obstructive sleep apnoea or obstructive sleep apnea syndrome or Obstructive sleep apnea or parkinson's?
Do you have any of these conditions: Obstructive sleep apnea or obstructive sleep apnoea or parkinson disease or Parkinson's disease or parkinson's or obstructive sleep apnea syndrome?
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note