Auricular Laser Acupuncture for Improving Sleep in Breast Cancer Patients (NCT07547423) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Auricular Laser Acupuncture for Improving Sleep in Breast Cancer Patients
Taiwan70 participantsStarted 2026-04-01
Plain-language summary
The goal of this clinical trial is to learn if auricular laser acupuncture can improve sleep quality and alleviate related symptoms in female breast cancer patients aged 18 to 75 with insomnia. The main questions it aims to answer are:
1. Does active auricular laser acupuncture improve sleep quality and reduce the severity of insomnia?
2. Does it help lower levels of cancer-related fatigue, anxiety, and depression?
Researchers will compare an active auricular laser acupuncture group to a sham control group (receiving no therapeutic laser energy) to see if active laser acupuncture is effective for symptom relief.
Participants will:
1. Receive 10 sessions of laser treatment (active or sham) twice a week for 5 weeks, while wearing protective goggles to ensure blinding.
2. Wear an actigraphy wristband and keep a sleep diary to monitor sleep patterns, and undergo heart rate variability (HRV) measurements at baseline and Week 5 (post-treatment).
3. Complete questionnaires assessing sleep, fatigue, mood, and quality of life at baseline, Week 5 (post-treatment), and Week 10 (follow-up).
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pittsburgh Sleep Quality Index (PSQI)
Timeframe: base line, 5 weeks (after treatment session)