Clinical trial · Interventional
Auricular Laser Acupuncture for Improving Sleep in Breast Cancer Patients
Efficacy of Auricular Laser Acupuncture for Insomnia in Breast Cancer Patient: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Females | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| auricular laser acupuncture | Device | — | UNRESOLVED |
| sham auricular laser acupuncture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- laser acupuncture
- interventionNames
- Device: auricular laser acupuncture
- type
- SHAM_COMPARATOR
- label
- sham laser acupuncture
- interventionNames
- Device: sham auricular laser acupuncture
Primary outcomes (1)
- measure
- Pittsburgh Sleep Quality Index (PSQI)
- timeFrame
- base line, 5 weeks (after treatment session)
- description
- Total scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality).
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available