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Trans-auricular Nerve Stimulation for Pain in Pediatric Sickle Cell Disease

This study is looking at a device called Sparrow Link tAN, an adhesive earpiece, to help treat pain in children with Sickle Cell Disease (SCD). This device works by stimulating nerves near the ear. The study wants to see if using the tAN device is practical and well-tolerated by children aged 7 to 18 who are hospitalized for a sickle cell pain crisis. You can join if you have sickle cell anemia (HbSS), normal outer ear anatomy, and have been hospitalized for a pain crisis before. The study will measure how many participants complete the study, how well they tolerate the stimulation, and if they find the intervention acceptable. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
What's involved
You would use the tAN device for an average of 3-7 days. During this time, your stimulation tolerability and acceptability of the intervention will be measured daily.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, such as completion rate, stimulation tolerability, and acceptability, are measured through study completion (an average of 3-7 days).

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NCT07090668

Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease

Recruiting
NAAges 7–18InterventionalTreatment
Emory University
~20 participants
Updated 2026-01-26 on ClinicalTrials.gov
What's tested:tAN device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility: Completion Rate
Measured over Through study completion (an average of 3-7 days)
+2 more outcomes measured

Conditions

Sickle Cell Disease

Explore related trials

Sickle Cell Disease

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Anna Woodbury, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Anna Woodbury, MD
[email protected]
470-882-8960
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Feasibility: Completion RateThrough study completion (an average of 3-7 days)

    Completion rate will be calculated by dividing the number of subjects who successfully used tAN for the duration of the trial, divided by the total number of subjects who participated in the trial. Subjects who prematurely opt to interrupt their participation in the study will not be included in the cohort of patients who successfully completed the study

  • Stimulation tolerabilityBaseline, everyday throughout the study (an average of 3-7 days)

    Stimulation tolerability will be evaluated daily during hospitalization by asking participants to describe any sensations experienced in response to percutaneous stimulation. Participants will be encouraged to express the sensation in their own words. The investigator will then further clarify the nature of the sensation-such as whether it feels like burning, tingling, or stabbing-to better characterize the participant's experience.

  • Acceptability of interventionBaseline, everyday throughout the study (an average of 3-7 days)

    Acceptability of intervention measure will be assessed using a standardized 4 item questionnaire.