Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea index (AHI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD consistent with the UK Brain Bank;
- •Presence of OSA on screening PSG, as defined by an AHI ≥ 15/h (moderate to severe OSA);
- •Stable regimen of anti-PD medication for 4 weeks prior to entry into the study, and no planned change during the study
排除标准
- •Other major neurological disorder;
- •Already taking long-acting levodopa (at any time of day);
- •Taking short-acting levodopa at bedtime or during the night;
- •Any contraindication to long-acting levodopa (see below);
- •Severe levodopa induced dyskinesias;
- •Already on or requiring treatment for restless legs syndrome ;
- •Body mass index >35 kg/m2;
- •Intercurrent upper respiratory tract infection;
- •Other known cause of OSA (e.g. craniofacial malformation);
- •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.
研究组 & 干预措施
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
干预措施: Placebo oral capsule (Drug)
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
干预措施: Sinemet CR (Drug)
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
干预措施: Sinemet CR (Drug)
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
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Apnea-hypopnea index (AHI)
时间窗: 2 weeks
次要结局
- Proportion of patients having adverse events leading to discontinuation of drug (Feasibility and tolerability)(2 weeks)
- Oxygenation from polysomnography(2 weeks)
- Non-motor symptoms(2 weeks)
- Objective sleep quality from polysomnography(2 weeks)
- Subjective sleep quality(2 weeks)
- Daytime sleepiness(2 weeks)
- Cognitive function(2 weeks)
研究者
Marta Kaminska
Assistant Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre