Evaluation of the Effect of Combined Music on Sleep Disorder

China Medical University

Status: Enrolling

Conditions: Sleep Disorder

Treatments: Other: five-element music therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05739773

CMUH110-REC1-170 (Other Identifier)

P11001

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Study

Experimental group

Description:

the five-element music group

Treatment:

Other: five-element music therapy

Control

Placebo Comparator group

Description:

binaural beats group

Treatment:

Other: five-element music therapy