Evaluation of Physiological Effects Induced by Low Level Light Irradiation on the Acupoints of the Hand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Heart rate variability of Healthy Participant during Low-Energy LED Therapy
研究概览
简要总结
The goal of this clinical trial is to determine if low-level laser therapy (LLLT) and LED-based low-level light therapy (LLLT) are effective in inducing relaxation and improving sleep quality and anxiety levels in individuals with insomnia. It aims to evaluate the potential of both light sources to elicit comparable physiological changes in relation to acupoint stimulation.
The main questions this trial aims to answer are:
Does exposure to low-level laser or LED light therapy on specific acupoints associated with insomnia result in similar changes in heart rate variability and meridian energy? How does skin pigmentation affect the penetration of different wavelength light sources used in LLLT? Primary hypothesis 1: Low-level LED light therapy is comparable to laser therapy in terms of effectiveness.
Primary hypothesis 2: With proper design, both treatments will elicit similar changes in meridian energy and heart rate variability.
Researchers will compare the effects of low-level laser and LED light therapy on 60 participants, divided into two groups: 30 healthy participants receiving either low-level laser/sham laser or low-level LED/sham LED light exposure and 30 participants with brown to black skin tones receiving different LED and laser specifications.
Participants will:
Undergo either low-level laser/sham laser or low-level LED/sham LED light exposure on specific acupoints.
Have their heart rate variability and meridian energy levels measured before and after the intervention.
Have their skin pigmentation measured to assess light penetration with various wavelengths.
This study seeks to establish a stronger link between acupoint stimulation, light therapy, and sleep neuroscience, potentially offering an alternative therapeutic approach for insomnia that complements existing pharmacological interventions.
详细描述
Research Background： In recent years, acupuncture has emerged as a promising therapeutic approach for improving sleep quality in menopausal women, particularly in addressing the challenging aspect of deepening sleep. This has led to an increased focus on acupunctural treatments, including acupoint stimulation, as a potential solution for insomnia. However, with increasingly stringent medical regulations, even non-invasive low-level laser therapy, despite its significantly safer profile compared to traditional acupuncture needles, faces substantial regulatory hurdles.
Meanwhile, novel LED technology presents a compelling alternative to lasers. Compared to lasers of equivalent power, LEDs boast lower costs, energy consumption, and operating temperatures without compromising therapeutic efficacy. This makes LED-based low-level light therapy (LLLT) a highly promising approach, especially for applications where diverse medical needs are present, such as in organizations like NASA.
This study is a preliminary investigation into the application of acupoint light therapy within the realm of Traditional Chinese Medicine (TCM) for managing insomnia and anxiety. The objective is to evaluate the potential of both low-level laser therapy and low-level LED light therapy, under similar power and wavelength conditions, to induce comparable physiological changes and consequently improve sleep quality and alleviate anxiety.
Specifically, this research will examine whether exposure to either light source results in similar relaxation effects by analyzing relevant physiological indicators like heart rate variability parameters and conductive meridian (Jingluo) parameters - a measure of electrical resistance along meridians. Furthermore, this study will address the understudied influence of skin pigmentation on LLLT by conducting optical experiments to determine the penetration depth of light sources with varying wavelengths through different skin types. This will contribute to a more comprehensive understanding of the application of LLLT in acupoint stimulation.
Research Objectives:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No use of sleeping pills within the past 3 months.
- •Pittsburgh Sleep Quality Index (PSQI) < 5 points.
- •Body Mass Index (BMI): 18.5 < BMI <
- •Blood pressure: within normal range (<140 mmHg/90 mmHg).
- •Individuals with regular wake-sleep times: bedtime between 22:00 and 02:00.
排除标准
- •Individuals with insomnia and other sleep disorders.
- •Exclude those currently taking medications.
- •Individuals with cardiovascular diseases, cancer, psychiatric disorders, kidney diseases, diabetes, chronic illnesses, and physical discomfort.
- •Exclude individuals with addictions to smoking, alcohol, caffeine, and drugs.
- •Individuals with light sensitive skin.
结局指标
主要结局
Heart rate variability of Healthy Participant during Low-Energy LED Therapy
时间窗: Measure three times: before, during, and after, each lasting 5 minutes
Heart rate variability is measured by using Wegene Electrocardiogram Recorder (Medical Device License No. 004896 of the Ministry of Health): Developed by National Yang-Ming University and in cooperation with Wegene Technology, this handheld heart rate measurement system allows users to measure heart rate variability parameters in a relaxed manner and reflect the main parameters on the dashboard in real time. The primary unit of measure for heart rate variability (HRV). HRV reflects the variation in time between consecutive heartbeats(bpm), and this variation is typically very small, measured in milliseconds. HRV parameters includes Total Power, TP \[ln(ms²)\], Standard deviation of Normal to Normal R Wave, SDNN(ms²), High Frequency, HF \[ln(ms²)\], Low Frequency, LF \[ln(ms²)\], Very Low Frequency, VLF \[ln(ms²)\], percentage of HF(%), percentage of LF(%), LF/HF ratio.
次要结局
- Meridian Energy Measurement of Healthy Participant during Low-Energy LED Therapy.(Measure two times: before and after, each lasting for 6 minutes)