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临床试验/NCT05739773
NCT05739773招募中不适用

Evaluation of the Effect of Five Elements Music Combined With Binaural Beat on Sleep Disorder

China Medical University, Taiwan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
change meridian energy

研究概览

简要总结

The results of this study will provide an affordable, safe and scientific treatment for patients with sleep disorders, so that patients can improve their sleep quality at home.

详细描述

The population suffered from sleep disorders is raising year by year, it has increased much social costs and medical burdens, especially the spread of the COVID-19 epidemic has made it even worse recently. Although many studies in the past few years have found that the use of non-invasive music therapy (such as five-element music, music combined with binaural beats) can effectively improve sleep quality, however, there is a lack of rigorous study design and measurement tools (scientific instrument examination).

To explore the effects of short-term sleep quality in patients with sleep disorders after receiving five-element music therapy or binaural beats, and further explore the combination of the above two music therapies to verify its effectiveness in improving long-term sleep quality.

The first year study was a randomized single-blind trial. 60 patients with sleep disorders were randomly assigned to the five-element music group and binaural beats group for two consecutive nights treatment to verify their short-term effects and assess the differences between them; the second year study was a randomized controlled trial , 60 patients with sleep disorders were randomly assigned to the five-element music combined with binaural beats group and the control group for four-week follow-up treatment to verify their long-term results and evaluate the feasibility of home treatment. The main results were measured with meridian energy examination and polysomnography. Other secondary results include sleep-related questionnaires (including Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Berlin Questionnaire, Hospital Anxiety and Depression Scale).

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
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • sleep disorder
  • PSQI score > 5

排除标准

  • Using tranquilizers or taking drugs or foods (such as coffee or refreshing drinks)
  • Severe cardiopulmonary disease (heart failure or cardiopulmonary failure) or cancer
  • Kidney dialysis patients
  • Patients with cardiac rhythm regulators or built-in hearing aids
  • Pregnant women and women who are still breastfeeding

结局指标

主要结局

change meridian energy

时间窗: two consecutive nights

Meridian energy examination

polysomnography

时间窗: two consecutive nights

Polysomnography refers to a systematic process used to collect physiologic parameters during sleep

次要结局

  • Pittsburgh Sleep Quality Index(two consecutive nights)
  • Hospital Anxiety and Depression Scale(two consecutive nights)
  • Epworth Sleepiness Scale(two consecutive nights)
  • Berlin Questionnaire(two consecutive nights)

研究者

发起方
China Medical University, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yueh-Ting Tsai

Assistant professor

China Medical University, Taiwan

研究点 (1)

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