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Ear device shows promise for Cancer-Related sleeplessness

NCT ID NCT06006299

Symptom relief Sponsor: University of Alabama at Birmingham 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a noninvasive device that gently stimulates a nerve in the ear (taVNS) could help breast cancer patients with insomnia. Twenty adults with stage I-IV breast cancer who had trouble sleeping for at least three months took part. The main goal was to see if the approach was practical and well-tolerated, with sleep quality measured through surveys.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Sep 2023

Finished

Jul 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 years and older

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: 1. at least 18 years of age 2. diagnosed stage I-IV breast cancer 3. self-reported difficulty falling asleep, staying asleep, or waking up too early, for at least three nights per week for a duration of at least three months 4. beginning or worsening of sleep disturbance since cancer diagnosis (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?) 5. English-speaking Exclusion Criteria: 1. Are using a daily sleep aid except melatonin (use of a sleep aid as needed will be permitted, and use will be noted). 2. have a history of severe mental illness 3. have an implanted medical device of any type 4. have a history of seizures 5. have peripheral neuropathy including temporal mandibular disorders and Bells Palsy 6. have vasovagal syncope 7. have moderate to severe cognitive impairment 8. have \<6 months to live as determined by the physician

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm insomnia

As listed by the trial registrant

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

Breast cancer Insomnia

Contacts and locations

Locations

  • UAB Lakeshore Collaborative (WHARF)

    Birmingham, Alabama, 35209, United States

  • UAB Spain Rehabilitation Center

    Birmingham, Alabama, 35233, United States

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