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New wearable could spot opioid breathing danger

NCT ID NCT06442488

Knowledge-focused Sponsor: Jeffrey Joseph 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a wearable, wireless device that listens to breathing to detect when opioids cause dangerously slow or shallow breathing. Researchers enrolled 14 healthy volunteers to see how well the device works in noisy environments. The goal was to compare accuracy with and without special noise-canceling features.

What this could mean

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

Active substance
Wearable wireless acoustic respiratory monitoring system (device)
What this could lead to
If successful, this device could help doctors detect dangerous breathing problems caused by opioids earlier, potentially preventing emergencies.
What could go wrong
This was a small, early-stage study with only 14 people, testing accuracy in a controlled setting. Real-world performance may differ, and the device is not yet ready for clinical use.

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

14 people

The number who actually took part.

Started

May 2024

Finished

Sep 2024

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

14 participants that meet the inclusion/exclusion criteria. Approximately equal number of male/female participants.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 18 to 70 years. 2. BMI 20 to 38. 3. Subject understands the English language, understands the risks, benefits, and alternatives to this research study, and is willing and able to give written informed consent. Exclusion Criteria: 1. Age \<18 years\>70. 2. BMI \< 20 or \> 38. 3. Does not understand written and spoken English. 4. Anxiety or claustrophobia related to wearing a face mask. 5. History of skin irritation or inflammation related to the adhesive, adhesive tape, or materials used in the trachea sound sensor or facemask. 6. Active infection or inflammation of the skin above the proximal trachea. 7. Excessive facial hair that may prevent a tight seal around the facemask. 8. Unstable cardiac, vascular, pulmonary, hepatic, renal, immune function at the discretion of the investigator. 9. Pregnancy or breast feeding. 10. Current participation in an industry sponsored pharmaceutical study or a medical device study.

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Conditions

The condition(s) this trial relates to.

Clinical Deterioration respiratory failure

As listed by the trial registrant

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

Clinical deterioration Respiratory insufficiency

Contacts and locations

Locations

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

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