Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Emotional state
研究概览
简要总结
The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pittsburgh Sleep Quality Index score is 8 or above.
- •Early wakening ( 30 minutes before expected), or interruptted sleep for more than 30 minutes, lasting for more than 3 months.
排除标准
- •Movement disorder, inability to move independently.
- •Skin diseases, skin cancer, photosensitive skin diseases, or taking drugs that may cause photosensitivity (lithium salts, melatonin, antibiotics, A acid).
- •Eye diseases such as glaucoma, diabetic retinopathy, and cataracts.
- •Bipolar disorder.
- •Light-induced epilepsy.
- •Sleep disorders such as sleep apnea and involuntary leg twitching.
- •Currently taking sedative-hypnotic drugs or receiving other non-drug treatments.
- •Beck depression inventory-II score is greater than 13 points.
- •Those who use cardiac rhythm regulators or artificial cardiopulmonary pacemakers.
- •Acute illness.
- •Abnormal blood pressure or fever.
- •Pregnancy and pregnant women.
- •Special physical abnormalities and sensory nerve abnormalities.
- •Infectious diseases.
- •Coagulation disorder.
结局指标
主要结局
Emotional state
时间窗: Baseline and the third week.
Beck Depression Inventory-II ranges from 0 (better) to 63 (worse).
Actigraphy-derived sleep indicators
时间窗: Baseline and the third week.
Participants will continue to wear activity recording watches during the three weeks of the study. We will capture weekly average sleep duration, sleep onset latency, wake time after falling asleep, and sleep efficiency.
Sleep quality
时间窗: Baseline and the third week.
Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse).
Dim-light melatonin onset
时间窗: Baseline and the third week.
Participants will be required to provide saliva samples for melatonin analysis within their home environment. These samples will be collected at 30-minute intervals starting from 18:00 and continuing until 1 hour after their habitual sleep time on both the initial and final study dates. The concentration of salivary melatonin will be assessed utilizing a direct melatonin enzyme-linked immunosorbent assay (ELISA) kit. The Dim Light Melatonin Onset (DLMO) will be determined using the two standard deviation threshold method, which involves calculating the average of the first three melatonin data points and then adding two standard deviations to this average.
次要结局
- Daytime sleepiness(Baseline and the third week.)
研究者
Wan-Ju Cheng
Doctor
China Medical University Hospital