NCT07547423尚未招募不适用
Efficacy of Auricular Laser Acupuncture for Insomnia in Breast Cancer Patient: A Randomized Controlled Trial
CHING-RONG HUANG1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
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:
- Does active auricular laser acupuncture improve sleep quality and reduce the severity of insomnia?
- 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:
- Receive 10 sessions of laser treatment (active or sham) twice a week for 5 weeks, while wearing protective goggles to ensure blinding.
- 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).
- Complete questionnaires assessing sleep, fatigue, mood, and quality of life at baseline, Week 5 (post-treatment), and Week 10 (follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
laser acupuncture
Active Comparator
干预措施: auricular laser acupuncture (Device)
sham laser acupuncture
Sham Comparator
干预措施: sham auricular laser acupuncture (Device)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: base line, 5 weeks (after treatment session)
Total scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality).
次要结局
- 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))
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)(baseline, 5 weeks (after treatment session), 10 weeks (follow up))
- Generalized Anxiety Disorder-7 (GAD-7)(baseline, 5 weeks (after treatment session), 10 weeks (follow up))
- Patient Health Questionnaire-9 (PHQ-9)(baseline, 5 weeks (after treatment session), 10 weeks (follow up))
研究者
CHING-RONG HUANG
Attending Physican
Chung Shan Medical University
研究点 (1)
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