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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborator: Weston Brain Institute
• Treatments: Carbidopa, levodopa drug combination; Levodopa

Criteria

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.