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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Capsule 250 mg / 50 mg taken at bedtime
Capsule taken at bedtime
McGill University Health Centre
Montreal, Quebec, Canada
Apnea-hypopnea index (AHI)
Time frame: 2 weeks
Proportion of patients having adverse events leading to discontinuation of drug (Feasibility and tolerability)
Proportion of patients having adverse events leading to discontinuation of drug
Time frame: 2 weeks
Oxygenation from polysomnography
oxygen desaturation index
Time frame: 2 weeks
Oxygenation from polysomnography
mean oxygen saturation
Time frame: 2 weeks
Oxygenation from polysomnography
time with saturation below 90%
Time frame: 2 weeks
Objective sleep quality from polysomnography
Sleep efficiency
Time frame: 2 weeks
Objective sleep quality from polysomnography
total sleep time
Time frame: 2 weeks
Objective sleep quality from polysomnography
wake after sleep onset
Time frame: 2 weeks
Objective sleep quality from polysomnography
sleep stages distribution
Time frame: 2 weeks
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Objective sleep quality from polysomnography
arousal index
Time frame: 2 weeks
Subjective sleep quality
Parkinson's Disease Sleep Scale-R
Time frame: 2 weeks
Daytime sleepiness
Epworth Sleepiness Scale
Time frame: 2 weeks
Non-motor symptoms
MDS-UPDRS part I
Time frame: 2 weeks
Cognitive function
Montreal Cognitive Assessment (MoCA)
Time frame: 2 weeks