Ear zaps show promise for fibromyalgia pain and sleep

NCT ID NCT07173400

What the study statuses mean

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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 Results may not be published yet.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
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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This status has not been confirmed recently, so it may be out of date.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 tested a non-invasive device that sends mild electrical pulses to the ear to stimulate the vagus nerve, which helps control pain and stress. Thirty adults with fibromyalgia received either real or sham stimulation for 30 minutes daily, five days a week, over four weeks. Researchers measured changes in pain, sleep quality, sensitivity, and fear of movement to see if this drug-free approach could improve daily life.

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

Aug 2025

Finished

Oct 2025

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: Age between 18 and 65 years Diagnosis of fibromyalgia according to the 2016 revised ACR criteria Receiving stable pharmacological and/or non-pharmacological treatment for at least 3 months Ability to understand study procedures and provide informed consent Exclusion Criteria: Pregnancy History of epilepsy or cardiac arrhythmia Acute or chronic infection Heart failure (NYHA class II-IV) Renal failure stage II or higher Active malignancy Psychotic disorders or current psychiatric treatment Diagnosis of immune-mediated rheumatic disease

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Istanbul Medipol University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

    Istanbul, Bagcılar, 34815, Turkey (Türkiye)

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