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Smart sensors in baby helmets could revolutionize flat head treatment

NCT ID NCT06425172

Disease control Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This study tests a custom helmet fitted with temperature and pressure sensors to monitor how long and how well it is worn by infants being treated for flat head syndrome (plagiocephaly or brachycephaly). The goal is to see if the sensors can accurately track wear time and detect when the helmet fits poorly. Twelve infants who already need a helmet as standard care will participate, and parents will also report their experience.

What this could mean

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

Active substance
custom helmet with embedded temperature and pressure sensors
What this could lead to
If successful, this monitoring system could help doctors and parents ensure helmets are worn enough and fit properly, improving treatment outcomes for infants with flat head syndrome.
What could go wrong
This is a very small, early feasibility study with only 12 infants. The sensors may not be accurate enough, and results may not apply to all helmet types or all infants.

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.

Participants

12 people

The number who actually took part.

Started

Aug 2024

Finished

Mar 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.

Who is studied

Infants who are clinically indicated for cranial remolding orthoses.

Ages

3 to 18 months

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: * Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly) Exclusion Criteria: * non-English speaking caregivers * infants with craniosynostosis or those not indicated for cranial remolding * infants with developmental comorbidities which affect cranial growth

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Conditions

The condition(s) this trial relates to.

craniosynostosis Plagiocephaly Plagiocephaly, Nonsynostotic

As listed by the trial registrant

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

Brachycephaly Deformational plagiocephaly Deformational posterior plagiocephaly Plagiocephaly

Contacts and locations

Locations

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

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