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Could a headband ease ADHD symptoms while kids sleep?

NCT ID NCT06655610

Symptom relief Sponsor: Psychiatric Research Unit, Region Zealand, Denmark 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a non-drug device (Monarch eTNS) that gently stimulates a nerve in the face to help ease ADHD symptoms in children and teens aged 7 to 17. About 60 participants will use the real device or a sham (fake) device every night for four weeks. The main goal is to see if families find the device easy to use and if a larger study is possible.

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 60 people

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

Started

Dec 2024

Expected to finish

Nov 2026

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

7 to 17 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: * 7 to 17 years of age at the time of study enrollment. * A clinical diagnosis of ADHD according to criteria for ICD-10: F90.0, F91.0, F90.8, F90.9, F98.8C. The ADHD diagnosis must be verified by the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) using The Schedule for Affective Disorders and Schizophrenia for School-aged Children (K-SADS). * A score above 24 on the ADHD rating scale (ADHD-RS) at baseline. * Signed informed consent from parents/legal caretakers and from the patients aged ≥ 15. We will include treatment-naïve patients, patients who previously have received stimulant medication, and patients in stable, ongoing stimulant medication (methylphenidate or dexamphetamines/lisdexamphetamine) during the time of the trial. Exclusion Criteria: * Patients receiving atomoxetine and guanfacine at the time of study enrollment will be excluded all together * Epilepsy * Electronic or metallic implants. * Serious mental and/or somatic diseases other than ADHD, such as: * Pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9) * Schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29) * Mania or bipolar disorder (ICD-10 F30 and F31) * Depressive psychotic disorders (ICD-10 F32.3 + F33.3) * Substance dependence syndrome (ICD-10 F1x.2) * Cardio-vascular disorders * Cancer * An Intelligence quotient (IQ) below 70 measured by the Wechsler Intelligence Scale for Children * A substantial degree of restless sleep as reported by parents or caregivers and evaluated by the physician. * Other disabilities that may make use of Monarch problematic.

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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.

ADHD - attention deficit disorder with hyperactivity

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

  • Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, 4200 Slagelse, Denmark

    RECRUITING

    Slagelse, Region Sjælland, 4200, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.