Shanxi Key Laboratory of Artificial Intelligence Assisted Diagnosis and Treatment for Mental Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Differences in sleep duration between the first and eighth weeks
研究概览
简要总结
This prospective observational study enrolled adult volunteers for a sleep quality research study through a questionnaire survey distributed via a WeChat two-dimensional code from May 2021 to April 2022. Participants were exposed to flicker stimulation through a light and sound device for a duration of 8 weeks with daily monitoring.
详细描述
This prospective observational study enrolled adult volunteers for a sleep quality research study through a questionnaire survey distributed via a WeChat two-dimensional code from May 2021 to April 2022. Participants were exposed to flicker stimulation through a light and sound device for a duration of 8 weeks with daily monitoring.
A total of 37 participants underwent polysomnography (PSG) prior to the commencement of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of insomnia according to DSM-5 Cumulative score of ≥7 on the seven-factor components of the Pittsburgh Sleep Quality Index. Sleep disturbances manifest at least three times per week.
排除标准
- •Secondary insomnia related to other mental disorders Substance-induced sleep disorders Environmental sleep disorders Sleep apnea syndrome. Stroke patients Insomnia caused by physical diseases, Severe ophthalmic diseases Brain tumors Suspected or confirmed history of alcohol or drug abuse Psychoactive drugs Pregnancy Previous participation in clinical trials within the past three months Epilepsy or family history of epilepsy.
结局指标
主要结局
Differences in sleep duration between the first and eighth weeks
时间窗: 8 weeks
Keep sleep diaries for the first and eighth weeks of treatment. A comparison of average sleep duration （hour） between the first and eighth weeks of treatment.
Treatment adherence rate
时间窗: 8 weeks （56 days）
Participants adhered well to flicker therapy over eight weeks, as measured by the percentage of days they used the device out of the total days they were assigned to use it. Treatment adherence rate = days the patient completed treatment on time/56 days×100%
Differences in sleep onset latencies between the first and eighth weeks
时间窗: 8 weeks
Keep sleep diaries for the first and eighth weeks of treatment. A comparison of average sleep onset latencies （min）between the first and eighth weeks of treatment.
Differences in awakening times between the first and eighth weeks
时间窗: 8 weeks
Keep sleep diaries for the first and eighth weeks of treatment. A comparison of average waking times （times） between the first and eighth weeks of treatment.
Incidence rate of adverse reaction
时间窗: 8 weeks
Describe the specific situation of adverse reactions, including types, frequency, severity, and whether they have been relieved. Incidence rate of adverse reactions = number of people experiencing adverse reactions/total number of people participating in treatment x 100%
Patient treatment adherence rate
时间窗: 8 weeks （56 days）
Participants adhered well to flicker therapy over eight weeks, as measured by the percentage of days they used the device out of the total days they were assigned to use it. Patient treatment adherence rate = sum of all treatment adherence rates / number of patients participating in treatment×100%
次要结局
- pre-sleep efficiency.(pre-intervention)
- post-sleep efficiency.(8 weeks)
研究者
Yong Xu
Clinical Professor
The First Affiliated Hospital of Shanxi Medical University