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| Name | Class |
|---|---|
| Chung Shan Medical University | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laser acupuncture | Active Comparator |
| |
| sham laser acupuncture | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | Total scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality). | base line, 5 weeks (after treatment session) |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | Total scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality). | baseline, 10 weeks (follow up) |
| Objective Sleep Efficiency Assessed by Actigraph |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ching-Rong Huang | Contact | +886-4-24739595 #38206 | csh.y2080@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University Hospital | Taichung | Taiwan |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| 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) |
|
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:
| 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:
| 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:
| 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). | 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). | 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). | 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). | baseline, 5 weeks (after treatment session), 10 weeks (follow up) |
| D001523 |
| Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |