Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06983275, who can take part
Where in China
- Fudan UniversityShanghai, ChinaContact: Jia XiuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Jia Xiu
- Trial code
- NCT06983275
- Record updated
- 19 September 2025
- Original description
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.Read full original descriptionShow less
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
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: Use of any sleep-related medication within the past month; Currently participating in any form of cognitive behavioral therapy or neuromodulation intervention study; Substance abuse (including alcohol or drugs), defined as more than 14 drinks/week for males or 12 drinks/week for females; Presence of sleep disorders such as sleep apnea syndrome or restless legs syndrome; Patient Health Questionnaire-9 (PHQ-9) score > 15 or Generalized Anxiety Disorder-7 (GAD-7) score > 10; 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; Epworth Sleepiness Scale (ESS) score > 10; Working night shifts or rotating shifts.