Evaluation of the Effect of Combined Music on Sleep Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Sleep Disorder

Intervention / Treatment
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* Other: five-element music therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sleep disorder PSQI score > 5 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study<br>the five-element music group | Other: five-element music therapy<br>* music therapy<br>* Other names: binaural beats;|
| Placebo Comparator: Control<br>binaural beats group | Other: five-element music therapy<br>* music therapy<br>* Other names: binaural beats;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polysomnography | Polysomnography refers to a systematic process used to collect physiologic parameters during sleep | two consecutive nights | 
| change meridian energy | Meridian energy examination | two consecutive nights | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | sleep-related questionnaire | two consecutive nights | 
| Epworth Sleepiness Scale | sleep-related questionnaire | two consecutive nights | 
| Berlin Questionnaire | sleep-related questionnaire | two consecutive nights | 
| Hospital Anxiety and Depression Scale | sleep-related questionnaires | two consecutive nights |