Status:
RECRUITING
Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
Lead Sponsor:
Jia Xiu
Collaborating Sponsors:
Shanghai Minhang Central Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06983275
Start Date
September 1 2025
End Date
June 1 2027
Last Update
September 19 2025
Active Locations (1)
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1
Fudan University
Shanghai, Shanghai Municipality, China, 200433