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| Name | Class |
|---|---|
| Weston Brain Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (drug-placebo) | Experimental | Sinemet CR (Long-acting levodopa: levodopa 200mg/ carbidopa 50mg) followed by a washout period and placebo oral capsule, each taken at bedtime for 2 weeks |
|
| B (placebo-drug) | Experimental | Placebo oral capsule followed by a washout period and Sinemet CR (Long-acting levodopa: levodopa 200mg/ carbidopa 50mg), taken at bedtime for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinemet CR | Drug | Capsule 250 mg / 50 mg taken at bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea index (AHI) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
| Oxygenation from polysomnography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Kaminska, MD, MSc | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | Canada |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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| Placebo oral capsule | Drug | Capsule taken at bedtime |
|
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oxygen desaturation index
| 2 weeks |
| Oxygenation from polysomnography | mean oxygen saturation | 2 weeks |
| Oxygenation from polysomnography | time with saturation below 90% | 2 weeks |
| Objective sleep quality from polysomnography | Sleep efficiency | 2 weeks |
| Objective sleep quality from polysomnography | total sleep time | 2 weeks |
| Objective sleep quality from polysomnography | wake after sleep onset | 2 weeks |
| Objective sleep quality from polysomnography | sleep stages distribution | 2 weeks |
| Objective sleep quality from polysomnography | arousal index | 2 weeks |
| Subjective sleep quality | Parkinson's Disease Sleep Scale-R | 2 weeks |
| Daytime sleepiness | Epworth Sleepiness Scale | 2 weeks |
| Non-motor symptoms | MDS-UPDRS part I | 2 weeks |
| Cognitive function | Montreal Cognitive Assessment (MoCA) | 2 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |