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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Quebec
      • Montreal, Quebec, Canada
        • McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A (drug-placebo)
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
Capsule 250 mg / 50 mg taken at bedtime
Other Names:
  • Long acting levodopa
Capsule taken at bedtime
Other Names:
  • Placebo
Experimental: B (placebo-drug)
Placebo oral capsule followed by a washout period and Sinemet CR (Long-acting levodopa: levodopa 200mg/ carbidopa 50mg), taken at bedtime for 2 weeks
Capsule 250 mg / 50 mg taken at bedtime
Other Names:
  • Long acting levodopa
Capsule taken at bedtime
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Apnea-hypopnea index (AHI)
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients having adverse events leading to discontinuation of drug (Feasibility and tolerability)
Time Frame: 2 weeks
Proportion of patients having adverse events leading to discontinuation of drug
2 weeks
Oxygenation from polysomnography
Time Frame: 2 weeks
oxygen desaturation index
2 weeks
Oxygenation from polysomnography
Time Frame: 2 weeks
mean oxygen saturation
2 weeks
Oxygenation from polysomnography
Time Frame: 2 weeks
time with saturation below 90%
2 weeks
Objective sleep quality from polysomnography
Time Frame: 2 weeks
Sleep efficiency
2 weeks
Objective sleep quality from polysomnography
Time Frame: 2 weeks
total sleep time
2 weeks
Objective sleep quality from polysomnography
Time Frame: 2 weeks
wake after sleep onset
2 weeks
Objective sleep quality from polysomnography
Time Frame: 2 weeks
sleep stages distribution
2 weeks
Objective sleep quality from polysomnography
Time Frame: 2 weeks
arousal index
2 weeks
Subjective sleep quality
Time Frame: 2 weeks
Parkinson's Disease Sleep Scale-R
2 weeks
Daytime sleepiness
Time Frame: 2 weeks
Epworth Sleepiness Scale
2 weeks
Non-motor symptoms
Time Frame: 2 weeks
MDS-UPDRS part I
2 weeks
Cognitive function
Time Frame: 2 weeks
Montreal Cognitive Assessment (MoCA)
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2017

Primary Completion (Actual)

October 28, 2022

Study Completion (Actual)

October 28, 2022

Study Registration Dates

First Submitted

March 28, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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