Actively Recruiting
Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
Led by Jia Xiu · Updated on 2025-09-19
120
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
J
Jia Xiu
Lead Sponsor
S
Shanghai Minhang Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years, regardless of gender
- Diagnosed with chronic insomnia disorder according to DSM-5 criteria, with difficulty falling asleep (sleep onset latency > 30 minutes), occurring at least 3 times per week, lasting more than 3 months but less than 3 years
- Able to independently operate a smartphone and complete self-reported assessments and self-administer the intervention after instruction
You will not qualify if you...
- Presence of sleep disorders such as sleep apnea syndrome or restless legs syndrome
- Epworth Sleepiness Scale (ESS) score greater than 10
- Use of any sleep-related medication within the past month
- Patient Health Questionnaire-9 (PHQ-9) score greater than 15 or Generalized Anxiety Disorder-7 (GAD-7) score greater than 10
- Currently participating in any cognitive behavioral therapy or neuromodulation intervention study
- Working night shifts or rotating shifts
- Clinically diagnosed neurological disorders such as epilepsy, stroke, dementia, Parkinson's disease, or psychiatric disorders including 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
J
Jia Xiu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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