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Could a simple ear device ease hEDS symptoms?

NCT ID NCT06548594

Symptom relief Sponsor: Medical University of South Carolina 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a wearable device that delivers mild electrical stimulation to the ear in 30 adults with hypermobile Ehlers-Danlos syndrome (hEDS). The goal was to see if it could improve quality of life by reducing symptoms like pain, fatigue, sleep problems, and anxiety. Participants used the device at home, and researchers measured changes using a symptom questionnaire.

What this could mean

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

Active substance
Transcutaneous Auricular Neurostimulation (tAN) device
What this could lead to
If it works, this could offer a new, at-home way to ease symptoms like pain, fatigue, and anxiety for people with hEDS.
What could go wrong
This was a small, early study with only 30 participants and no control group. Results may not apply to everyone, and the device may not work for all symptoms.

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

30 people

The number who actually took part.

Started

Nov 2024

Finished

Mar 2026

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 to 65 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: * Ages of 18 and 65; * Participants who meet the 2017 diagnostic criteria for hEDS or HSD4-5 with persistent symptoms in at least two of the domains to be followed during the intervention (pain, fatigue, sleep, anxiety, depression, quality of life, GI function, autonomic function and immune function) * Mentally capable of reading, writing, giving consent, and following instructions; Exclusion Criteria: * Mentally capable of reading, writing, giving consent, and following instructions; * Not pregnant; * No history of seizures; * no prior history of trauma or damage to ear * History of documented Autism spectrum disorder (ASD) diagnosis * Residing in the state of South Carolina

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Conditions

The condition(s) this trial relates to.

Ehlers-Danlos syndrome, hypermobility type hypermobility spectrum disorder

As listed by the trial registrant

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

Hypermobile eds (HEDS)

Contacts and locations

Locations

  • Medical University of South Carolina Institute of Psychiatry

    Charleston, South Carolina, 29425, United States

More trials for these conditions

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