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Could a tiny ear device ease severe PMS and menopause symptoms?

NCT ID NCT07688720

Symptom relief Sponsor: Texas Christian University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether a small, wearable device that gently stimulates nerves in the ear can improve mood and physical symptoms in women with premenstrual dysphoric disorder (PMDD) or perimenopause. Participants use the device daily and report their symptoms through online surveys. The goal is to see if this non-invasive approach offers relief without medication.

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 (Sparrow Link)
What this could lead to
If it works, this could offer a drug-free, at-home option for managing PMDD and perimenopause symptoms.
What could go wrong
This is a very small early study (20 people) with no control group, so results may not be conclusive or generalizable.

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 20 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Mar 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 55 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.

PMS/PMDD Study: Inclusion Criteria: * Assigned female at birth * Age 18 to 45 * Naturally cycling * Regularly occurring menstrual cycle * Must identify as having PMS or PMDD * Reliable ability to complete online study surveys Exclusion Criteria: * Using hormonal birth control * Pregnant or lactating/breastfeeding * History of seizures * Implanted devices * Current or previous diagnosis of any heart conditions * Abnormal ear anatomy * Non-removable piercings on the ear * Recent ear infection * Taking SSRIs * Taking steroids * Taking hormone therapy * If the participant anticipates starting or stopping prescription medications during the study period * Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.) * Participant has a history traumatic brain injury within the past 12 months * Must not have any other mental illness or mood disorder Perimenopause Study: Inclusion Criteria: * Assigned female at birth. * Age 40 to 55 * Must have newly variable menstrual cycles or report identifying as perimenopausal * Reliable ability to complete online study surveys Exclusion Criteria: * Using hormonal birth control * Pregnant or lactating/breastfeeding * History of seizures * Implanted devices * Current or previous diagnosis of any heart conditions * Abnormal ear anatomy * Non-removable piercings on the ear * Recent ear infection * Taking SSRIs * Taking steroids * Taking hormone therapy * If the participant anticipates starting or stopping prescription medications during the study period. * Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.) * Participant has a history traumatic brain injury within the past 12 months * have a hysterectomy In both studies we will confirm that participants are symptomatic shortly following enrollment.

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Conditions

The condition(s) this trial relates to.

premenstrual dysphoric disorder premenstrual tension

As listed by the trial registrant

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

Perimenopause PMDD

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

  • Texas Christian University

    RECRUITING

    Fort Worth, Texas, 76109, United States

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