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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
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)
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)
Chung Shan Medical University Hospital
Taichung, Taiwan
Pittsburgh Sleep Quality Index (PSQI)
Total scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality).
Time frame: base line, 5 weeks (after treatment session)
Pittsburgh Sleep Quality Index (PSQI)
Total scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality).
Time frame: baseline, 10 weeks (follow up)
Objective Sleep Efficiency Assessed by Actigraph
Objective parameters are recorded via wrist-worn ActiGraph monitor over 7 continuous days (5 weekdays, 2 weekends) per assessment to calculate daily averages. Metrics include: 1. Sleep Efficiency: Ratio of Total Sleep Time to Time in Bed (range: 0-100%). Higher values indicate a better outcome. 2. Total Sleep Time: Measured in minutes. Higher values indicate a better outcome. 3. Sleep Latency: Measured in minutes. Lower values indicate a better outcome. 4. Wake After Sleep Onset (WASO): Measured in minutes. Lower values indicate a better outcome. 5. Number of Awakenings: Count per period. Lower values indicate a better outcome. 6. Average Awakening Duration: Measured in minutes. Lower values indicate a better outcome.
Time frame: baseline, 5 weeks (after treatment session)
Subjective Sleep Quality Assessed by Sleep Diary
Subjective sleep parameters are recorded via daily sleep diary over 7 continuous days (5 weekdays, 2 weekends) per assessment to calculate daily averages. Metrics include: 1. Subjective Sleep Quality: Self-rated 5-point scale (range: 1-5; 1=Very Poor, 5=Very Good). Higher scores indicate a better outcome. 2. Total Sleep Time: Measured in minutes. Higher values indicate a better outcome. 3. Sleep Latency: Measured in minutes. Lower values indicate a better outcome. 4. Number of Awakenings: Count per night. Lower values indicate a better outcome. 5. Night Awakening Duration: Measured in minutes. Lower values indicate a better outcome.
Time frame: baseline, 5 weeks (after treatment session)
Autonomic Nervous System Function Assessed by Short-Term Heart Rate Variability (HRV)
Short-term (5-minute) resting HRV is measured to evaluate autonomic nervous system function. The metrics extracted for analysis include: 1. SDNN (Standard Deviation of NN intervals): Measured in milliseconds (ms). Higher values indicate a better outcome. 2. Total Power (TP): Measured in ms². Higher values indicate a better outcome. 3. HF (High Frequency power): Reflects parasympathetic activity, measured in ms². Higher values indicate a better outcome. 4. LF/HF Ratio: Calculated as the ratio of Low Frequency to High Frequency power. Lower values indicate a better outcome (reduced sympathetic hyperarousal).
Time frame: baseline, 5 weeks (after treatment session)
Functional Assessment of Cancer Therapy - Breast (FACT-B)
Total scores range from 0 to 148. Higher scores indicate a better outcome (better health-related quality of life).
Time frame: baseline, 5 weeks (after treatment session), 10 weeks (follow up)
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)
Total scores range from 0 to 52. Higher scores indicate a better outcome (less fatigue).
Time frame: baseline, 5 weeks (after treatment session), 10 weeks (follow up)
Generalized Anxiety Disorder-7 (GAD-7)
Total scores range from 0 to 21. Higher scores indicate a worse outcome (greater severity of anxiety).
Time frame: baseline, 5 weeks (after treatment session), 10 weeks (follow up)
Patient Health Questionnaire-9 (PHQ-9)
Total scores range from 0 to 27. Higher scores indicate a worse outcome (greater severity of depression).
Time frame: baseline, 5 weeks (after treatment session), 10 weeks (follow up)
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