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Could a simple ear device ease fibromyalgia pain and fatigue?

NCT ID NCT07682090

Symptom relief Sponsor: University of Roma La Sapienza Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether a non-invasive device that stimulates a nerve in the ear can help people with fibromyalgia. Participants use the device for 30 minutes daily over four weeks. The goal is to see if it reduces pain, fatigue, and other symptoms by calming the body's stress response.

What this could mean

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

Active substance
transcutaneous vagus nerve stimulation (tVNS) device
What this could lead to
If effective, this could offer a drug-free, at-home option to reduce pain, fatigue, and other fibromyalgia symptoms.
What could go wrong
This is a small, early-stage trial. The sham control may show no difference, and benefits may not last beyond the four-week treatment period.

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 80 people

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

Started

Jun 2026

Expected to finish

Sep 2027

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 to 70 years

Sex

Female participants only

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 fibromyalgia syndrome according to the 2016 ACR/EULAR classification criteria; * Stable pharmacological treatment for at least 1 month before enrollment; * Ability to understand and complete study procedures and questionnaires; * Ability to provide written informed consent. Exclusion Criteria: * Presence of an active implantable medical device or any implanted metallic or electronic device near the ear or heart; * History of severe coronary artery disease or myocardial infarction; * Heart failure classified as New York Heart Association (NYHA) class II-IV; * Cardiac arrhythmias or severe bradycardia; * Carotid artery atherosclerosis; * Chronic kidney disease stage II or higher; * Concomitant immune-mediated rheumatic disease; * Pregnancy; * Active malignancy or previous malignancy not in remission; * Ongoing infection; * Changes in pharmacological treatment within 1 month before enrollment; * Concomitant central or peripheral nervous system disorders, except isolated small-fiber pathology on skin biopsy; * Cognitive impairment detected during neurological examination; * Severe psychiatric comorbidities requiring specific treatment; * Pain caused by other medical conditions that cannot be distinguished from fibromyalgia-related pain; * Current or previous alcohol or substance abuse; * Inadequate understanding of the Italian language.

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Conditions

The condition(s) this trial relates to.

fibromyalgia

As listed by the trial registrant

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

Fibromyalgia syndrome

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

  • Department of Human Neuroscience

    RECRUITING

    Rome, Lazio, 00185, Italy

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