Breast Cancer FemalesNCT07547423
Auricular Laser Acupuncture for Improving Sleep in Breast Cancer Patients
A study testing auricular laser acupuncture in people with Breast Cancer Females and Insomnia, run by CHING-RONG HUANG at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Females, Insomnia
- What is being tested?
- auricular laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Aug 2026to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University Hospital
Taichung
Ching Rong Huang, Doctor of Medicine (M.D.), +886-4-24739595 #38206, csh.y2080@gmail.com
About this study
Official title: 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:
- Does active auricular laser acupuncture improve sleep quality and reduce the severity of insomnia?
- Does it help lower levels of cancer-related fatigue, anxiety, and depression?
Read more
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:
- Receive 10 sessions of laser treatment (active or sham) twice a week for 5 weeks, while wearing protective goggles to ensure blinding.
- 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).
- Complete questionnaires assessing sleep, fatigue, mood, and quality of life at baseline, Week 5 (post-treatment), and Week 10 (follow-up).
- Conditions
- Breast Cancer Females, Insomnia
- Being tested
- auricular laser acupuncture, sham auricular laser acupuncture
- Keywords
- Breast Cancer, Insomnia, Auricular Laser Acupuncture
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular laser acupunctureDevice
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 acupunctureDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| laser acupuncture | Active comparator | Not described Receives: Device: auricular laser acupuncture |
| sham laser acupuncture | Sham comparator | Not described Receives: Device: sham auricular laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
Total scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality).
Measured: base line, 5 weeks (after treatment session)
Secondary outcomes (8)
Pittsburgh Sleep Quality Index (PSQI)
Total scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality).
Measured: 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:
- Sleep Efficiency: Ratio of Total Sleep Time to Time in Bed (range: 0-100%). Higher values indicate a better outcome.
- Total Sleep Time: Measured in minutes. Higher values indicate a better outcome.
- Sleep Latency: Measured in minutes. Lower values indicate a better outcome.
- Wake After Sleep Onset (WASO): Measured in minutes. Lower values indicate a better outcome.
- Number of Awakenings: Count per period. Lower values indicate a better outcome.
- Average Awakening Duration: Measured in minutes. Lower values indicate a better outcome.
Measured: 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:
- Subjective Sleep Quality: Self-rated 5-point scale (range: 1-5; 1=Very Poor, 5=Very Good). Higher scores indicate a better outcome.
- Total Sleep Time: Measured in minutes. Higher values indicate a better outcome.
- Sleep Latency: Measured in minutes. Lower values indicate a better outcome.
- Number of Awakenings: Count per night. Lower values indicate a better outcome.
- Night Awakening Duration: Measured in minutes. Lower values indicate a better outcome.
Measured: 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:
- SDNN (Standard Deviation of NN intervals): Measured in milliseconds (ms). Higher values indicate a better outcome.
- Total Power (TP): Measured in ms². Higher values indicate a better outcome.
- HF (High Frequency power): Reflects parasympathetic activity, measured in ms². Higher values indicate a better outcome.
- LF/HF Ratio: Calculated as the ratio of Low Frequency to High Frequency power. Lower values indicate a better outcome (reduced sympathetic hyperarousal).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: baseline, 5 weeks (after treatment session), 10 weeks (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start26 Aug 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHING-RONG HUANG
- Sponsor type
- University, hospital or other
- Collaborators
- Chung Shan Medical University
- Responsible party
- Sponsor-investigator, CHING-RONG HUANG, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547423
- Sponsor's protocol ID
- CS2-25177
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided