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Can a laser on your ear cure insomnia in breast cancer patients?

NCT ID NCT07547423

Symptom relief Sponsor: CHING-RONG HUANG 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a low-level laser applied to specific points on the ear can improve sleep in women with breast cancer who have insomnia. Seventy participants will receive either real or sham laser acupuncture twice a week for five weeks. Sleep quality, fatigue, and mood will be measured using questionnaires and a wrist-worn activity tracker.

What this could mean

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

Active substance
auricular laser acupuncture
What this could lead to
If it works, this could offer a non-drug option to help breast cancer patients sleep better and reduce fatigue, anxiety, and depression.
What could go wrong
This is a small, early-stage trial with only 70 participants. The sham control may also show some benefit, and results may not apply to all patients. No serious risks are expected, but the laser device may not provide meaningful benefit over placebo.

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 70 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jul 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 75 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: * Aged between 18 and 75 years. * Histologically confirmed breast cancer, TNM stage I-III. * Meets the DSM-5 diagnostic criteria for insomnia. * Willing to participate in the study (completion of at least 8 out of 10 treatment sessions). * Able to provide signed informed consent. * No use of sedative-hypnotic medications other than Stilnox, Ativan, Xanax, or Eurodin within the past three months. Exclusion Criteria: * Currently undergoing or planning to undergo chemotherapy, radiotherapy, or surgical treatment during the study period. * Other sleep disorders (e.g., sleep apnea, restless legs syndrome). * Severe physical or psychiatric comorbidities. * Has an implanted cardiac pacemaker. * History of epilepsy. * Taking gametocides or immunosuppressants. * Pregnant. * Substance abuse or alcoholism. * Participated in other clinical trials within the past three months, or concurrent participation during the study period. * Unable to cooperate with the assessment procedures.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm female breast carcinoma insomnia

As listed by the trial registrant

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

Breast cancer females Insomnia

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

  • Chung Shan Medical University Hospital

    Taichung, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.