Recruiting

Auricular Laser Acupuncture for Improving Sleep in Breast Cancer Patients

ClinicalTrials.gov IDNCT07547423

PhaseNA

Enrollment70

SponsorCHING-RONG HUANG

Age18 Years – 75 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer Females, Insomnia

About this study

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).

Interventions

Device: auricular laser acupuncture — Using laser pen to stimulation ear acupoint at Shenmen, Subcortex, Heart, Kidney, Occiput, and Sympathetic points, administered for 15 minutes per session, twice weekly, for 5 weeks (10 sessions)
Device: sham auricular laser acupuncture — Using laser pen WITH NO LASER OUTPUT to stimulation ear acupoint at Shenmen, Subcortex, Heart, Kidney, Occiput, and Sympathetic points, administered for 15 minutes per session, twice weekly, for 5 weeks (10 sessions)

Primary outcomes

Pittsburgh Sleep Quality Index (PSQI) (base line, 5 weeks (after treatment session))

Eligibility information

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.

Study locations

Chung Shan Medical University Hospital, Taichung, Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-15.