Auricular Laser Acupuncture for Improving Sleep in Breast Cancer Patients

Efficacy of Auricular Laser Acupuncture for Insomnia in Breast Cancer Patient: A Randomized Controlled 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).

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.