Auricular Laser Acupuncture for Improving Sleep in Breast Cancer Patients

April 16, 2026 updated by: CHING-RONG HUANG

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Chung Shan Medical University Hospital
        • Contact:
          • Ching Rong Huang, Doctor of Medicine (M.D.)
          • Phone Number: +886-4-24739595 #38206
          • Email: csh.y2080@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laser acupuncture
Device: auricular laser acupuncture
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 Comparator: sham laser acupuncture
Device: sham auricular laser acupuncture
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: base line, 5 weeks (after treatment session)
Total scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality).
base line, 5 weeks (after treatment session)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: baseline, 10 weeks (follow up)
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
Time Frame: 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.
baseline, 5 weeks (after treatment session)
Subjective Sleep Quality Assessed by Sleep Diary
Time Frame: 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.
baseline, 5 weeks (after treatment session)
Autonomic Nervous System Function Assessed by Short-Term Heart Rate Variability (HRV)
Time Frame: 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).
baseline, 5 weeks (after treatment session)
Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time Frame: 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).
baseline, 5 weeks (after treatment session), 10 weeks (follow up)
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)
Time Frame: 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).
baseline, 5 weeks (after treatment session), 10 weeks (follow up)
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 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).
baseline, 5 weeks (after treatment session), 10 weeks (follow up)
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 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).
baseline, 5 weeks (after treatment session), 10 weeks (follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHING-RONG HUANG

Collaborators

Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS2-25177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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