Non-motor Features of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Sleep duration using Actigraph
研究概览
简要总结
50 participants with Parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. For this, participants will wear an Actigraph for seven days. Thirty of these participants with sleep disturbance will go on to receive a tailored lighting intervention (TLI) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.
详细描述
Participants will undergo one week of baseline data collection using the actigraph and light meter and one night of an overnight urine collection. At the completion of the baseline week, the lighting intervention will be installed in the participants' home. Participants will be exposed to the lighting intervention for 2 hours each morning after awakening for 8 weeks. During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days and collect one overnight urine sample. Participants will complete questionnaires before and after the intervention to further assess its effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 Parkinson's disease and difficulties with sleep and/or cognition
排除标准
- •There are no exclusion criteria
研究组 & 干预措施
Tailored Lighting Intervention (TLI)
The TLI will be performed for 2 hours each day over an 8-week period
During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days
干预措施: Tailored Lighting Intervention (TLI) (Device)
Tailored Lighting Intervention (TLI)
The TLI will be performed for 2 hours each day over an 8-week period
During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days
干预措施: Actigraph (Device)
结局指标
主要结局
Sleep duration using Actigraph
时间窗: at Week 8 for 7 days
Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.
次要结局
- Sleep efficiency using Actigraph(at Week 8 for 7 days)
- Urine melatonin levels(at Week 8)
研究者
Rachel Saunders-Pullman
Professor
Icahn School of Medicine at Mount Sinai