Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index Scale(PSQI)
研究概览
简要总结
Study Purpose The purpose of this clinical trial is to investigate whether low-intensity frontal vibration can improve sleep performance in individuals with chronic insomnia. Additionally, the study aims to explore its potential effects on memory enhancement.
The primary objectives of the study are to address the following questions:
- Does low-intensity frontal vibration improve sleep performance in patients with chronic insomnia?
- Does low-intensity frontal vibration enhance memory performance in patients with chronic insomnia?
Researchers will compare the effects of low-intensity frontal vibration with a sham stimulation (in which participants hear only noise associated with the vibration process) to determine whether the active intervention can effectively improve symptoms of chronic insomnia.
Participant Involvement
Participants in the study will:
- Record daily sleep diaries via a mobile application for a total of 9 weeks
- Receive daily intervention during a 4-week intervention phase as scheduled by the study
- Complete weekly self-reported sleep questionnaires through the app
- Undergo memory performance assessments at the beginning and end of the study
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years, regardless of gender;
- •Diagnosed with chronic insomnia disorder according to DSM-5 criteria, with a primary complaint of difficulty falling asleep (sleep onset latency > 30 minutes), occurring ≥3 times per week, lasting for more than 3 months but less than 3 years;
- •Able to independently operate a smartphone, and capable of completing self-reported assessments and applying the self-administered intervention after instruction.
排除标准
- •Presence of sleep disorders such as sleep apnea syndrome or restless legs syndrome;
- •Epworth Sleepiness Scale (ESS) score > 10;
- •Use of any sleep-related medication within the past month;
- •Patient Health Questionnaire-9 (PHQ-9) score > 15 or Generalized Anxiety Disorder-7 (GAD-7) score > 10;
- •Currently participating in any form of cognitive behavioral therapy or neuromodulation intervention study;
- •Working night shifts or rotating shifts;
- •Clinically diagnosed neurological disorders such as epilepsy, stroke, dementia, or Parkinson's disease, or psychiatric disorders such as bipolar disorder, obsessive-compulsive disorder, phobias, or panic disorder;
- •Substance abuse (including alcohol or drugs), defined as more than 14 drinks/week for males or 12 drinks/week for females.
研究组 & 干预措施
Control group
The control group is designed to serve as a comparison to the intervention group, to determine whether the intervention produces real therapeutic effects. Participants in the control group will take part in a 9-week study, consisting of:
- Week 1 (Adaptation Phase): Daily sleep diary recording
- Weeks 2-5 (Intervention Phase): Daily sham stimulation and sleep diary recording
- Weeks 6-9 (Follow-up Phase): Daily sleep diary recording Memory performance assessments will be conducted within one week following the adaptation phase and again within one week after the follow-up phase. Participants will also complete a sleep questionnaire once per week throughout the study.
干预措施: Sham (Other)
Intervention group
The intervention group is designed to verify whether the stimulation yields true therapeutic effects in comparison to the control group. Participants in the intervention group will also undergo a 9-week study, consisting of:
- Week 1 (Adaptation Phase): Daily sleep diary recording
- Weeks 2-5 (Intervention Phase): Daily active stimulation and sleep diary recording
- Weeks 6-9 (Follow-up Phase): Daily sleep diary recording Memory performance assessments will be conducted within one week following the adaptation phase and again within one week after the follow-up phase. Participants will complete a sleep questionnaire once per week throughout the study.
干预措施: Vibrational stimulation (Device)
结局指标
主要结局
Pittsburgh Sleep Quality Index Scale(PSQI)
时间窗: baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up)
A scale that evaluates sleep quality, the scale scores range from 0 to 21, and lower scores mean a better outcome
次要结局
- Patient Health Questionnaire (PHQ-9)(baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up))
- Sleep Diary(Daily recording for the duration of the 63-day trial.)
- The Insomnia Severity Index Scale(ISI)(baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each weekduring 4-week follow-up))
- Epworth Sleepiness Scale(ESS)(baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up))
- Generalized Anxiety Disorder-7 (GAD-7)(baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up))
- Memory Task(baseline(Day 1); intervention stage(The last day of 4-week intervention, an average of Day 35); follow-up stage(The last day 4-week stage, an average of Day 63))
- Intervention Experience(through study completion, an average of 63 days)
研究者
Jia Xiu
doctoral student
Fudan University