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Ear zap could replace pills for sickle cell pain in kids

NCT ID NCT07090668

Symptom relief Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a small device that gently stimulates nerves in the ear to see if it can help relieve pain in children with sickle cell disease during a pain crisis. About 20 children hospitalized for pain will try the device. The main goal is to see if kids can tolerate it and find it helpful, while also checking if it reduces pain and inflammation.

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 20 people

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

Started

Aug 2025

Expected to finish

Jul 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

7 to 18 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: * Diagnosis of sickle-cell anemia (HbSS) * Normal outer ear anatomy and intact skin for tAN placement * Hospitalized for a pain crisis and experiencing pain as a result of SCD * Patients must have had at least one prior hospitalization for a sickle cell pain crisis in the past Exclusion Criteria: * History of seizures * History of uncontrolled psychiatric illness * Repeated episodes of autonomic instability (apnea or bradycardia) that are not self-resolving * Cardiomyopathy * Diagnosis of Acute Chest Syndrome * Unrepaired congenital anomalies affecting the cardiovascular or respiratory system * Hemodynamically unstable patients * Females who are pregnant or lactating. Subjects who refuse a pregnancy test. * Women of childbearing potential, not using adequate contraception as per the investigator's judgment, or not willing to comply with contraception for the duration of the study * Patients with a history of surgery within the last 3 months * Patients who suffered from a stroke within the last 3 months * Patient admitted with a fever or who develops a fever throughout their hospitalization * Patients whose disease-modifying therapy (HU, chronic transfusions, etc.) and/or pain medications (gabapentin, pregabalin, etc.) have not yet reached a steady dose * Patients who have had 3 or more hospitalizations for acute pain crises in a given year

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Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

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

Sickle cell disease

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Children's Hospital of Atlanta: Eagelston

    RECRUITING

    Atlanta, Georgia, 30329, United States

More trials for these conditions

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