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Smart patch listens for breathing danger in opioid patients

NCT ID NCT07217197

Diagnosis Sponsor: Thomas Jefferson University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a wearable device that listens to breathing sounds through a sensor on the throat. It aims to detect and predict opioid-induced respiratory depression (slow or stopped breathing) in 120 adults recovering from surgery. The device's accuracy will be compared to standard monitors like pulse oximeters and capnometers.

What this could mean

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

Active substance
Wearable Respiratory Monitoring System (RMS) with Tracheal Sound Sensor (TSS)
What this could lead to
If successful, this device could help doctors spot dangerous breathing problems early in patients taking opioids after surgery, potentially preventing emergencies.
What could go wrong
This is an early-stage study with only 120 participants, so the device may not work as well in real-world settings. It is not a treatment and does not replace standard monitoring.

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 120 people

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

Started

Jan 2026

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

18 years and older

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. Surgical patients routinely managed post-op with opioid medication as their primary analgesic for break through pain. 2. Age ≥ 18 years 3. BMI 20 to 40 4. American Society of Anesthesiologists physical status I, II, and III. 5. Understands written and spoken English language Exclusion Criteria: 1. Age \< 18 years. 2. BMI \< 20 or \> 40. 3. American Society of Anesthesiologists physical status IV and V. 4. Active Do Not Resuscitate (DNR) order. 5. Does not understand written and spoken English well. 6. Anxiety or claustrophobia related to wearing a face mask or nasal cannula. 7. History of skin irritation or inflammation related to the adhesives or materials used in the TSS sensor, facemask, nasal cannula, or pulse oximeter probe. 8. Active infection or inflammation of the skin above the proximal trachea. 9. Anticipated hospital length of stay less than 24 hours. 10. Excessive facial hair that may prevent attachment of the RMS sensor 11. Unstable cardiovascular or pulmonary function or any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff (e.g., known history of hepatitis B or C). 12. Pregnancy or breast feeding. 13. 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.

Respiration Disorders Respiratory Aspiration respiratory failure respiratory system disorder

As listed by the trial registrant

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

Respiration disorders

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

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