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Can wireless monitors make ER vitals easier for autistic children?

NCT ID NCT07828964

Diagnosis Sponsor: Hamilton Health Sciences Corporation 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Autistic children in the emergency department often miss full vital sign checks because standard equipment can be distressing. This pilot study randomizes 100 children aged 2 to 17 to have their heart rate, breathing, oxygen and temperature measured either with wireless wearable monitors plus standard equipment, or with standard equipment alone. Researchers want to see whether the wearable approach is feasible, whether it speeds up vital sign collection, and whether it reduces distress without safety concerns.

What this could mean

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

Active substance
wireless wearable vital sign monitors (Masimo Radius PPG and Radius T)
What this could lead to
If the approach works, emergency staff could get complete vital signs faster and with less distress for autistic children, and the results could shape a larger trial.
What could go wrong
This is a small, single-centre pilot with 100 children, so it cannot prove the monitors improve care. Some children may not tolerate the devices, and the study may not show a clear benefit.

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 100 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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

2 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: 1. Age 2 to 17 years 2. Suspected or confirmed ASD diagnosis by chart or caregiver 3. Presenting to ED visit and requiring vital signs 4. Anatomically suitable sites for device placement 5. Participant with capacity (including a mature minor) or caregiver/substitute decision-maker able to complete the informed consent process in English. Certified interpreters will not be used to translate the research consent process in this pilot because validated translated consent documents are unavailable. 6. Ability to observe the child for at least 30 minutes to measure time-to-vitals and r-FLACC and CFS scores Exclusion Criteria: 1. CTAS 1 2. Skin conditions or isolation precautions preventing device placement 3. Implanted or adjacent devices that could interfere with sensors 4. Prior enrollment in the study 5. Known allergy or hypersensitivity to foam rubber, adhesive tape, or device adhesive components.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

Autism spectrum disorder

How to take part

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  1. 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 ↗

  2. A doctor treating you

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