Health TrialsbyHealthPanel

Auricular Laser Acupuncture for Improving Sleep in Breast Cancer Patients

ConditionsBreast Cancer FemalesInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCHING-RONG HUANG

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: laser acupunctureActive comparator 1 intervention
Group B: sham laser acupunctureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CHING-RONG HUANG

Lead sponsor

Chung Shan Medical University

Sponsor institution

Chung Shan Medical University

Collaborator

Source ClinicalTrials.gov
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