Efficacy of Auricular Laser Acupuncture for Insomnia in Breast Cancer Patient: A Randomized Controlled Trial
| Registry | NCT07547423 |
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| Status | Recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 70 (Estimated) |
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| Sponsor | CHING-RONG HUANG (Other); collaborators: Chung Shan Medical University |
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| Conditions | Breast Cancer Females, Insomnia |
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| Interventions | auricular laser acupuncture, sham auricular laser acupuncture (Device) |
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| Dates | start 2026-08-26, primary completion 2027-06-30 (estimated), completion 2027-07-31 (estimated), first posted 2026-04-23, last updated 2026-10-07 |
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| Locations | 1 site in Taiwan |
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Related Papers Related Patents Related Grants Related Experts
All trials for Breast Cancer Females All trials for Insomnia All trials of auricular laser acupuncture All trials of sham auricular laser acupuncture
-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).
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| laser acupuncture | Active comparator | Device: auricular laser acupuncture | |
| sham laser acupuncture | Sham comparator | Device: sham auricular laser acupuncture | |
- auricular laser acupuncture (Device): 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)
- sham auricular laser acupuncture (Device): 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)
+Outcome measures
Primary outcomes
- Pittsburgh Sleep Quality Index (PSQI) [base line, 5 weeks (after treatment session)]: Total scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality).
Secondary outcomes
- Pittsburgh Sleep Quality Index (PSQI) [baseline, 10 weeks (follow up)]: Total scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality).
- Objective Sleep Efficiency Assessed by Actigraph [baseline, 5 weeks (after treatment session)]: 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.
- Subjective Sleep Quality Assessed by Sleep Diary [baseline, 5 weeks (after treatment session)]: 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.
- Autonomic Nervous System Function Assessed by Short-Term Heart Rate Variability (HRV) [baseline, 5 weeks (after treatment session)]: 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).
- Functional Assessment of Cancer Therapy - Breast (FACT-B) [baseline, 5 weeks (after treatment session), 10 weeks (follow up)]: Total scores range from 0 to 148. Higher scores indicate a better outcome (better health-related quality of life).
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) [baseline, 5 weeks (after treatment session), 10 weeks (follow up)]: Total scores range from 0 to 52. Higher scores indicate a better outcome (less fatigue).
- Generalized Anxiety Disorder-7 (GAD-7) [baseline, 5 weeks (after treatment session), 10 weeks (follow up)]: Total scores range from 0 to 21. Higher scores indicate a worse outcome (greater severity of anxiety).
- Patient Health Questionnaire-9 (PHQ-9) [baseline, 5 weeks (after treatment session), 10 weeks (follow up)]: Total scores range from 0 to 27. Higher scores indicate a worse outcome (greater severity of depression).
+Eligibility
Sex: Female, ages: 18 Years to 75 Years
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.
+Locations (1)
| Facility | City | Country | Status |
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| Chung Shan Medical University Hospital | Taichung | Taiwan | Recruiting |