Frontal vibration to improve sleep and memory in chronic insomnia

Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

This study will test whether gentle low‑intensity vibrations applied to the forehead help adults with chronic insomnia sleep better and improve memory.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06983275 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with DSM‑5 chronic insomnia characterized by sleep‑onset latency >30 minutes at least three nights per week for over three months, who can operate a smartphone and self‑administer the device.

Not a fit: People with other sleep disorders (such as sleep apnea or restless legs), high daytime sleepiness (ESS >10), recent use of sleep medications, severe depression or anxiety, current CBT or neuromodulation therapy, night/rotating shift workers, or diagnosed neurological disorders are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the intervention could provide a non‑drug, easy‑to‑use option to shorten time to fall asleep and potentially improve memory for people with chronic insomnia.

How similar studies have performed: Vibrational neuromodulation for insomnia is relatively novel; related noninvasive neuromodulation methods (for example transcranial stimulation) have produced mixed but sometimes promising results in prior studies.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jia Xiu, PhD

Conditions Chronic Insomnia; chronic insomnia; vibrational neuromodulation; vibration