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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111485
• Other study ID #: MP-37-2017-2573
• Status: Completed
• Phase: Phase 4
• Start date: May 24, 2017
• Est. completion date: October 28, 2022

Study information

• Verified date: March 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Parkinson Disease
• Parkinson's Disease
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Sinemet CR
Capsule 250 mg / 50 mg taken at bedtime
• Placebo oral capsule
Capsule taken at bedtime

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Weston Brain Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index (AHI)		2 weeks
Secondary	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
Secondary	Oxygenation from polysomnography	oxygen desaturation index	2 weeks
Secondary	Oxygenation from polysomnography	mean oxygen saturation	2 weeks
Secondary	Oxygenation from polysomnography	time with saturation below 90%	2 weeks
Secondary	Objective sleep quality from polysomnography	Sleep efficiency	2 weeks
Secondary	Objective sleep quality from polysomnography	total sleep time	2 weeks
Secondary	Objective sleep quality from polysomnography	wake after sleep onset	2 weeks
Secondary	Objective sleep quality from polysomnography	sleep stages distribution	2 weeks
Secondary	Objective sleep quality from polysomnography	arousal index	2 weeks
Secondary	Subjective sleep quality	Parkinson's Disease Sleep Scale-R	2 weeks
Secondary	Daytime sleepiness	Epworth Sleepiness Scale	2 weeks
Secondary	Non-motor symptoms	MDS-UPDRS part I	2 weeks
Secondary	Cognitive function	Montreal Cognitive Assessment (MoCA)	2 weeks