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Ear device zaps vagus nerve in bid to quiet long COVID fatigue and brain fog

NCT ID NCT06585254

Symptom relief Sponsor: Icahn School of Medicine at Mount Sinai 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 22, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This trial tests whether a small device that stimulates the vagus nerve through the ear can improve quality of life for people with long COVID who also meet the criteria for ME/CFS (chronic fatigue syndrome). Participants will use the device daily for six weeks, and researchers will compare two different stimulation settings to see which one works better. The goal is to reduce fatigue, pain, post-exertional malaise, and brain fog.

What this could mean

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

Active substance
a device that gently stimulates the vagus nerve through the ear (transcutaneous vagus nerve stimulation)
What this could lead to
If it works, this could point toward a drug-free way to manage debilitating symptoms like fatigue, pain, and brain fog in long COVID and ME/CFS.
What could go wrong
This is a small, early-stage trial comparing two stimulation settings, not a proven treatment. The device may not help, and some people may find the stimulation uncomfortable.

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 50 people

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

Started

Nov 2024

Expected to finish

Feb 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

21 to 70 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: * Must have had documented Covid infection and then fulfill 2015 case definition for ME/CFS * Chalder Fatigue Scale score of 4 or greater * SF-36 Physical Function scale score ≤70 * VAS values of 3 or higher from 0 \[none\] 3 \[substantial\] to 5 \[very severe burden\] on at least two of the following symptoms - fatigue; widespread pain, brain fog, post-exertional malaise Exclusion Criteria: * BMI ≥30 * Hospitalized for COVID-19 infection * BMI ≥30 * Pregnancy

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Conditions

The condition(s) this trial relates to.

long COVID-19 myalgic encephalomeyelitis/chronic fatigue syndrome

As listed by the trial registrant

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

Chronic fatigue syndrome Long COVID

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

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