Auricular Laser Acupuncture for Sleep in Breast Cancer Patients
Official title: Efficacy of Auricular Laser Acupuncture for Insomnia in Breast Cancer Patient: A Randomized Controlled Trial
Run by Chung Shan Medical University · NCT07547423 · Data updated 2026-11-12
This trial tests whether active auricular laser acupuncture can improve sleep in women with breast cancer and insomnia compared with a sham laser.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 70 (estimated) |
| Sponsor | Chung Shan Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taichung) |
| Status | Recruiting |
| Started | August 26, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07547423 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–75 with histologically confirmed breast cancer (stage I–III) and insomnia who consent and complete at least 8 of 10 sessions.
✕Probably not a fit
Patients who do not respond to acupuncture or have contraindications to laser treatment may not experience sleep improvement.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with breast cancer and insomnia will be randomized to receive 10 sessions of either active or sham auricular laser acupuncture over five weeks, with sleep tracked by wearables and diaries, plus heart rate variability measurements. The study uses blinding with sham treatment and blinded assessment to see if laser acupuncture helps sleep quality and related symptoms. Sleep questionnaires, actigraphy, and HRV data will be collected at baseline and after treatment to evaluate changes. Eligible participants are women 18–75 with stage I–III breast cancer not undergoing concurrent cancer therapy during the study.
Why it matters
Potential benefit: If successful, patients may experience improved sleep quality and reduced fatigue, anxiety, and depression related to breast cancer.
How similar studies have gone: Previous work on auricular acupuncture suggests potential for symptom relief, but evidence for laser-based approaches in this population is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Chung Shan Medical University Hospital
Taichung, Taiwan Recruiting
Study contacts
- Study coordinator: Ching-Rong Huang
- Email: csh.y2080@gmail.com
- Phone: +886-4-24739595 #38206
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.