Frontal vibration to improve sleep and memory in chronic insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18–65 with DSM‑5 chronic insomnia will be enrolled and trained to self‑apply a low‑intensity frontal vibration device at home. Participants will be assigned to receive either active vibration or a sham stimulation and will complete daily self‑administered sessions for four weeks while recording sleep diaries via a mobile app for nine weeks. Sleep outcomes and memory performance will be measured to compare the active intervention against sham noise‑only stimulation. The design aims to separate true physiological effects of vibration from placebo or expectation effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jia Xiu, PhD
• Email: 22110850035@m.fudan.edu.cn
• Phone: +86 15552382909

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A smart look at common sleep meds for insomnia

  This trial tests how well and how safely widely used sleep medicines and OTCs work for adults with insomnia and which might be best overall.

  Recruiting Phase 4 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07542756

• Transcranial alternating current stimulation for generalized anxiety disorder and chronic insomnia

  This study will try 20 sessions of transcranial alternating current stimulation (tACS) with the Nexalin device to see if it improves anxiety and sleep in adults with generalized anxiety disorder and chronic insomnia.

  Recruiting University of Sao Paulo · São Paulo, São Paulo · NCT07429578

• Adding yoga to usual care for adults with chronic insomnia

  This trial will test whether doing a structured yoga program alongside usual care helps adults (18–65) with chronic insomnia sleep better than usual care alone.

  Recruiting All India Institute of Medical Sciences · New Delhi, National Capital Territory of Delhi · NCT07419152

• SWELL cognitive behavioral therapy program for chronic insomnia in older Veterans

  This project will try two ways of rolling out SWELL, a five-session CBT for chronic insomnia, to help older Veterans get and benefit from treatment.

  Recruiting VA Office of Research and Development · Durham, North Carolina · NCT07216261

• Restoring everyday health and wellbeing by improving sleep

  This study will try Cognitive Behavioral Therapy for Insomnia (CBT-I) in adults with chronic insomnia to see if better sleep changes stress-hormone (cortisol) patterns and improves daytime health, especially for people who sleep less than six hours a night.

  Recruiting University of Notre Dame · Notre Dame, Indiana · NCT07156383

• Brief group Acceptance and Commitment Therapy (ACT-i) for adults with chronic insomnia

  This project will test whether a short, group Acceptance and Commitment Therapy program (ACT-i) helps adults aged 18–59 with chronic insomnia compared with an attentional control program.

  Recruiting Babes-Bolyai University · Cluj-Napoca · NCT07048600

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.