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Head vibration device tested as new insomnia fix

NCT ID NCT06983275

Symptom relief Sponsor: Jia Xiu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether wearing a vibrating device on the forehead for 15 minutes before bed can improve sleep and memory in people with chronic insomnia. 120 adults aged 18-65 with trouble falling asleep will use either the active device or a sham version for 4 weeks. Participants track sleep via a phone app and complete memory tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vibration stimulation device
What this could lead to
If it works, this could offer a simple, drug-free way to improve sleep quality and memory in people with chronic insomnia.
What could go wrong
This is an early-stage study with a small number of participants. The effect may be small or no better than a placebo, and long-term benefits are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic insomnia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

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