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Not yet recruiting NCT07547423

Auricular Laser Acupuncture for Improving Sleep in Breast Cancer Patients

No phase Interventional Breast Cancer Females Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: auricular laser acupuncture, sham auricular laser acupuncture.
Who it may be relevant to
Registry conditions: Breast Cancer Females, Insomnia. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy of Auricular Laser Acupuncture for Insomnia in Breast Cancer Patient: A Randomized Controlled Trial

Overview

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).

Interventions

  • 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)
  • 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)

Primary outcome measures

  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: base line, 5 weeks (after treatment session)]
Secondary outcome measures (8)
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: baseline, 10 weeks (follow up)]
  • Objective Sleep Efficiency Assessed by Actigraph [Time frame: baseline, 5 weeks (after treatment session)]
  • Subjective Sleep Quality Assessed by Sleep Diary [Time frame: 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)]
  • Functional Assessment of Cancer Therapy - Breast (FACT-B) [Time frame: 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)]
  • Generalized Anxiety Disorder-7 (GAD-7) [Time frame: 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Chung Shan Medical University Hospital — Taichung

Identifiers

NCT: NCT07547423 · CS2-25177

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗