NCT07547423

Brief 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. 1.Does active auricular laser acupuncture improve sleep quality and reduce the severity of insomnia?
  2. 2.Does it help lower levels of cancer-related fatigue, anxiety, and depression?
  3. 3.Receive 10 sessions of laser treatment (active or sham) twice a week for 5 weeks, while wearing protective goggles to ensure blinding.
  4. 4.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).
  5. 5.Complete questionnaires assessing sleep, fatigue, mood, and quality of life at baseline, Week 5 (post-treatment), and Week 10 (follow-up).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Jul 2027

First Submitted

Initial submission to the registry

April 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

April 1, 2026

Last Update Submit

April 16, 2026

Conditions

InsomniaBreast Cancer Females

Keywords

Breast CancerInsomniaAuricular Laser Acupuncture

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (8)

  • Pittsburgh Sleep Quality Index (PSQI)

    baseline, 10 weeks (follow up)

  • Objective Sleep Efficiency Assessed by Actigraph

    baseline, 5 weeks (after treatment session)

  • Subjective Sleep Quality Assessed by Sleep Diary

    baseline, 5 weeks (after treatment session)

  • Autonomic Nervous System Function Assessed by Short-Term Heart Rate Variability (HRV)

    baseline, 5 weeks (after treatment session)

  • Functional Assessment of Cancer Therapy - Breast (FACT-B)

    baseline, 5 weeks (after treatment session), 10 weeks (follow up)

  • +3 more secondary outcomes

Study Arms (2)

laser acupuncture

ACTIVE COMPARATOR
Device: auricular laser acupuncture

sham laser acupuncture

SHAM COMPARATOR
Device: sham auricular laser acupuncture

Interventions

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)

laser acupuncture
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)

sham laser acupuncture

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersBreast Neoplasms

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Ching-Rong Huang

CONTACT

+886-4-24739595 #38206csh.y2080@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Physican

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 23, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

TW(1)