NCT03111485

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will assess whether long-acting levodopa taken at night improves obstructive sleep apnea (OSA) in patients with Parkinson's disease (PD), as compared with placebo.

Detailed description

Participants with Parkinson's disease and sleep apnea will take long-acting levodopa and placebo at bedtime for 2 weeks each, in a randomized order, with a 2-week washout period in-between. Sleep studies will be done at the end of each period. The primary outcome will be the apnea-hypopnea index change from baseline to on-medication, comparing active medication to placebo. Other outcomes will include other polysomnographic parameters such as oxygenation measures and sleep architecture variables, as well as the Epworth Sleepiness Scale, the Montreal Cognitive Assessment, the Parkinson's disease sleep scale and the Unified Parkinson's Disease Rating Scale. Adverse events will be closely monitored.

Conditions

• Parkinson's Disease
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Sinemet CR	Capsule 250 mg / 50 mg taken at bedtime
DRUG	Placebo oral capsule	Capsule taken at bedtime

Timeline

• Start date: 2017-05-24
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2017-04-12
• Last updated: 2024-03-13

Locations

1 site across 1 country: Canada