Effect of Low Level Light Irradiation on Insomniacs' Meridians During the First Sleep Cycle.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Differences in sleep EEG before and after the laser irradiation compared to the sham group
研究概览
简要总结
Introduction In the past, it was found that stimulating the meridians and acupoints with low-level light often had a good effect. However, for safety reasons, most instruments such as laser acupuncture devices still need to be used by medical personnel, and it is difficult to apply to insomnia patients at bed-time or the first sleep cycle, these two periods have a considerable impact on sleep quality.
Therefore, the purpose of this study is to provide a safer wearable light-therapy device for Insomnia patients, so that it can be used in home sleep situations, and the improvement of subjects' sleep qualtity and meridian energy will be evaluated by PSG, HRV parameters, sleep questionnaires, and Ryodoraku value (reflects the meridian electric resistance).
Methods Aim1: To evaluate whether the subjects are more relaxed by observing the changes in heart rate and meridian energy of healthy subjects after low-level light irradiating to Shenmen, Daling, Neiguan (acupoints for insomnia). We also consider the difference of light source and the skin color in experiment design. Aim2: To assess whether the insomnia patients' sleep quality has improved after applying the wearable light therapy device to subjects' bed-time (include the first sleep cycle). We use PSG, sleep questionnaires, stroop test for evaluation.
详细描述
Hypotheses and Aims
In the past, there are no studies on using light acupuncture during the first sleep cycle or bed-time. So, we have the following hypotheses: First, irradiating low level light on the sleep acupoints during these periods will strengthen the activity of the parasympathetic during these periods; Second, the activity of the parasympathetic will improve the quality of sleep in the first sleep cycle, because the parasympathetic activity of sleep onset(SO) is an indicator of sleep quality; Third, the improvement of sleep quality in the first sleep cycle will affect the quality of total sleep and daytime cognitive functions. I divide the research hypotheses for details into three categories:
Part 1: To observe the relationship between light stimulation of traditional Chinese medicine (TCM) sleep-aiding acupoints.
Hypothesis 1-1: After the laser stimulates the sleep-aiding acupoints, the energy of the meridian that is too high will decrease, and the energy of the meridian that is too low will increase.
Hypothesis 1-2: After laser acupuncture, the qi of the meridians will not be consumed too quickly like acupuncture, so the needle retention is safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
participants allocation by third party
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
- •aged 20 to 65 years
- •No sleep pills for 3 months
- •Body Mass Index (BMI) : 18.5-30
- •Blood pressure: within normal range (140 mmHg/90 mmHg)
- •People with regular wake-up time
- •The bedtime is between 22:00 and 2:00.
排除标准
- •People with sleep disorders other than insomnia
- •those currently taking drugs;
- •with cardiovascular disease, cancer, psychiatric disease, kidney disease, diabetes, chronic disease and physical discomfort
- •Exclude tobacco, alcohol, caffeine, and drug addicts
- •Exclude from fitzpatrick skin type classification - V and VI (skin is black and dark brown)
- •People whose skin is allergic to light (light sensitivity, solar dermatitis).
结局指标
主要结局
Differences in sleep EEG before and after the laser irradiation compared to the sham group
时间窗: Change from Baseline sleep EEG at 67 days
According to sleep EEG,we can analysis participants' brain waves (alpha,beta,theta,delta) and sleep stages,etc. to evaluate their objective sleep quality
Differences in Heart rate variability before and after the laser irradiation compared to the sham group
时间窗: Change from heart rate variability parameters at 67 days
HRV is measured by the variations in the R-R interval between the successive peaks of the QRS complex in the ECG wave. Based on fast Fourier transform, time-domain (R-R interval) transfer to frequency domain resulting total power (TP, 0.04-0.15), low frequency (LF, 0.06-0.6Hz), high frequency (HF, 0.6-2.4Hz), normalized LF (LF%) and LF/HF ratio are obtained. LF% and HF represent an index of sympathetic activity and parasympathetic activity respectively. LF/HF is indicative of the sympathetic to parasympathetic autonomic balance.
次要结局
- Differences in the Epworth Sleepiness Scale (ESS) before and after the laser irradiation compared to the sham group.(Change from Baseline ESS at 67 days)
- Differences in Visual Analogue Scale (VAS) before and after the laser irradiation compared to the sham group.(Change from Baseline VAS at 67 days)
- Differences in scores of stroop test before and after the laser irradiation compared to the sham group.(Change from Baseline score of stroop at 67 days)
- Differences in the Insomnia Severity Index (ISI) before and after the laser irradiation compared to the sham group.(Change from Baseline ISI at 67 days)
- Differences in the Pittsburgh sleep quality index before and after the laser irradiation compared to the sham group.(Change from Baseline PSQI at 67 days)
- Differences in The Beck Depression Inventory II (BDI-II) before and after the laser irradiation compared to the sham group.(Change from Baseline BDI-II at 67 days)
- Differences in Beck Anxiety Inventory (BAI) before and after the laser irradiation compared to the sham group.(Change from Baseline BAI at 67 days)
- Differences in Chinese 14-item PSS before and after the laser irradiation compared to the sham group.(Change from Baseline PSS at 67 days)
研究者
vghtpe user
Center for Traditional Medicine,Attending Doctor, Principal Investigator,
Taipei Veterans General Hospital, Taiwan