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Earpiece could cut morphine use for Opioid-Dependent newborns

NCT ID NCT05129020

Symptom relief Sponsor: Spark Biomedical, Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a gentle nerve-stimulating earpiece can help newborns going through opioid withdrawal. The device is used up to four times a day for 20 days, just before each morphine dose. Researchers want to see if it reduces the number of days babies need morphine and how long they stay in the hospital.

What this could mean

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

Active substance
Sparrow Fledging Therapy System (a nerve-stimulating earpiece)
What this could lead to
If it works, this could offer a drug-free way to ease withdrawal in newborns, reducing their need for morphine and shortening hospital stays.
What could go wrong
This is a small, early-stage study with only 52 infants, so results may not apply to all babies. The sham group gets no stimulation, so any benefit might be due to placebo or natural recovery.

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

52 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

33 weeks to 1 year

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. Neonates or infants \>33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy 2. Clinically stable without respiratory support (exception for nasal cannula) 3. Congenital syndromes may be included if the infants do not have major, unrepaired anomalies Exclusion Criteria 1. Unstable infants 2. Repeated episodes of autonomic instability (apnea or bradycardia) which are not self-resolving 3. Major unrepaired congenital anomalies impacting respiratory or cardiovascular system 4. Cardiomyopathy 5. Abnormal ear anatomy preventing the device to fit 6. Infants diagnosed with iatrogenic NOWS 7. Infants two weeks of age or older (after birth) 8. Neonates who have received more than 6 methadone doses or 24 hours of methadone dosing 9. Infants who are wards of the state 10. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

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Conditions

The condition(s) this trial relates to.

neonatal abstinence syndrome substance withdrawal syndrome

As listed by the trial registrant

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

Neonatal abstinence syndrome Neonatal opioid withdrawal syndrome

Contacts and locations

Locations

  • Medical University of South Carolina - Shawn Jenkins Children's Hospital

    Charleston, South Carolina, 29425, United States

  • UT Southwestern Medical Center / Parkland Memorial Hospital

    Dallas, Texas, 75235, United States

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229, United States

More trials for these conditions

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