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Could a headband worn during sleep ease ADHD symptoms?

NCT ID NCT05374187

Symptom relief Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tested a non-invasive device that gently stimulates a nerve on the forehead (trigeminal nerve) during sleep to see if it can reduce ADHD symptoms in children ages 7 to 12. Over 200 children used either the active device or a sham (inactive) device nightly for 4 weeks. Researchers measured changes in ADHD rating scales and brain activity to see if the treatment works and how it might affect the brain.

What this could mean

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

Active substance
external trigeminal nerve stimulation (eTNS) device
What this could lead to
If it works, this could provide a safe, non-drug treatment option for children with ADHD, reducing symptoms without medication side effects.
What could go wrong
This is a completed early-stage trial with a modest sample size. The effect may be small or not last long, and the device may not work for all children.

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

218 people

The number who actually took part.

Started

Sep 2022

Finished

Apr 2026

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

7 to 12 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: 1. male and female children ages 7 to 12 years with DSM-5 ADHD, any current presentation, as determined by diagnostic interview, Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), and clinical interview; 2. total score \>= 24 on baseline ADHD-RS; 3. CGI-S score at baseline \>= 4; 4. no current medication with CNS effects (Participants previously on psychostimulant medication will be required to be not optimally treated and off medication for one week or 5 half-lives for all other medications); stable use of supplements will be permitted; 5. parents able and willing to monitor proper use of the stimulation device and complete all required rating scales; 6. estimated Full Scale IQ \>= 80 based on WASI subtests; 7. parent and participant able to complete rating scales and other measures in English; 8. able to cooperate during EEG Exclusion Criteria: 1. impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator; 2. current diagnosis of autism spectrum disorder or major depression; 3. history of lifetime psychosis, mania, or seizure disorder; 4. baseline suicidality; 5. history of seizure disorder or head injury with loss of consciousness

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder

As listed by the trial registrant

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

Attention deficit hyperactivity disorder

Contacts and locations

Locations

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

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