A Dose Selection Trial of Light Therapy for Impaired Sleep in Parkinson's Disease
概览
- 阶段
- 不适用
- 干预措施
- SunRay Light Boxes
- 疾病 / 适应症
- Parkinson Disease
- 发起方
- Massachusetts General Hospital
- 入组人数
- 203
- 试验地点
- 25
- 主要终点
- Parkinson's Disease Sleep Scale 2
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
This study aims to determine the most effective dose of light therapy to improve sleep in people with Parkinson's Disease. Four groups of participants will receive bright-white or dim-red light therapy at different times throughout the day.
详细描述
This is a 16-week, randomized, phase II, parallel-group, dose-selection clinical trial of LT in participants with PD and co-existing sleep disruption using a comparative selection trial design.
研究者
Aleksandar Videnovic, MD
Associate Professor of Neurology
Massachusetts General Hospital
入排标准
入选标准
- •Diagnosis of idiopathic PD as defined by the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease;
- •PD Hoehn and Yahr stage 2-4;
- •A score of 2 (mild) or above on the Sleep Problems question of the MDS-UPDRS Part 1;
- •Stable dose of all PD medications for at least 30 days prior to randomization;
- •Willingness to wear an Actiwatch and complete daily sleep logs;
- •Age 45 or above
排除标准
- •Atypical or secondary forms of parkinsonism;
- •Co-existent significant sleep apnea at screening, as determined by the PI's clinical assessment; adequately treated sleep apnea, as assessed by sleep apnea machine download (CPAP download) will be permitted;
- •Co-existent symptomatic restless legs syndrome (RLS) (as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS) at screening;
- •Cognitive impairment as determined by a Mini Mental State Examination score \<25 at screening;
- •Presence of moderate depression defined as a Beck Depression Inventory II (BDI-II) score ≥20 at screening;
- •Current untreated hallucinations or psychosis (drug-induced or spontaneous) with a score of 2 or above on the Hallucinations and Psychosis question of the MDS-UPDRS Part 2;
- •Use of hypno-sedative drugs for sleep or stimulants, unless the participant has been on a stable dose for at least 60 days prior to the screening;
- •Ongoing or recent (within 30 days prior to screening) Cognitive Behavioral Therapy for Insomnia;
- •Use of antidepressants, unless the participant has been on a stable dose for at least 60 days prior to the screening;
- •Work hours between 10 PM and 6 AM, within 60 days prior to randomization or anticipated during the 16 weeks after screening;
研究组 & 干预措施
BWLT weekly
Participants in this arm will receive bright white light therapy once weekly (in the evening).
干预措施: SunRay Light Boxes
BWLT once daily
Participants in this arm will receive bright white light therapy daily once a day (in the evening)
干预措施: SunRay Light Boxes
BWLT twice daily
Participants in this arm will receive bright white light therapy daily twice a day (morning and evening).
干预措施: SunRay Light Boxes
DRLT twice daily
Participants in this arm will receive dim red light twice daily (morning and evening).
干预措施: SunRay Light Boxes
结局指标
主要结局
Parkinson's Disease Sleep Scale 2
时间窗: 8 weeks
The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.
次要结局
- Parkinson's Fatigue Scale 16(8 weeks)
- Parkinson's Disease Sleep Scale 2(8 weeks)
- Adherence(8 weeks)