About this trial
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).
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- auricular laser acupuncture
- sham auricular laser acupuncture
Treatment groups
Sponsors and collaborators
CHING-RONG HUANG
Lead sponsor
Chung Shan Medical University
Sponsor institution
Chung Shan Medical University
Collaborator