Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT03111485
• Date of registration: 28/03/2017
• Prospective Registration: Yes
• Primary sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Public title: Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
• Scientific title: Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
• Date of first enrolment: May 24, 2017
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03111485
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Marta Kaminska, MD, MSc
• Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of idiopathic PD consistent with the UK Brain Bank;

2. Presence of OSA on screening PSG, as defined by an AHI = 15/h (moderate to severe
OSA);

3. Stable regimen of anti-PD medication for 4 weeks prior to entry into the study, and no
planned change during the study

Exclusion Criteria:

1. Other major neurological disorder;

2. Already taking long-acting levodopa (at any time of day);

3. Taking short-acting levodopa at bedtime or during the night;

4. Any contraindication to long-acting levodopa (see below);

5. Severe levodopa induced dyskinesias;

6. Already on or requiring treatment for restless legs syndrome ;

7. Body mass index >35 kg/m2;

8. Intercurrent upper respiratory tract infection;

9. Other known cause of OSA (e.g. craniofacial malformation);

10. Active treatment of OSA (CPAP, dental appliance or other), unless willing to stop
treatment 2 weeks prior to start and during the duration of the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Obstructive Sleep Apnea

Parkinson's Disease

Intervention(s)

Drug: Placebo oral capsule

Drug: Sinemet CR

Primary Outcome(s)

Apnea-hypopnea index (AHI) [Time Frame: 2 weeks]

Secondary Outcome(s)

Non-motor symptoms [Time Frame: 2 weeks]

Cognitive function [Time Frame: 2 weeks]

Subjective sleep quality [Time Frame: 2 weeks]

Oxygenation from polysomnography [Time Frame: 2 weeks]

Proportion of patients having adverse events leading to discontinuation of drug (Feasibility and tolerability) [Time Frame: 2 weeks]

Daytime sleepiness [Time Frame: 2 weeks]

Objective sleep quality from polysomnography [Time Frame: 2 weeks]

Secondary ID(s)

MP-37-2017-2573

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Weston Brain Institute