Evaluation of the Effect of Combined Music on Sleep Disorder

Not Applicable

Recruiting

• Conditions: Sleep Disorder
• Interventions: Other: five-element music therapy

• Registration Number: NCT05739773
• Lead Sponsor: China Medical University, Taiwan

Brief Summary

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

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).

Study Timeline

• Study Start: 2022-10-07
• Study First Submitted: 2022-11-05
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22
• Primary Completion: 2023-08-11
• Study Completion: 2023-10-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study	five-element music therapy	the five-element music group
Control	five-element music therapy	binaural beats group

Primary Outcome Measures

Name	Time	Method
change meridian energy	two consecutive nights	Meridian energy examination
polysomnography	two consecutive nights	Polysomnography refers to a systematic process used to collect physiologic parameters during sleep

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	two consecutive nights	sleep-related questionnaires
Epworth Sleepiness Scale	two consecutive nights	sleep-related questionnaire
Berlin Questionnaire	two consecutive nights	sleep-related questionnaire
Pittsburgh Sleep Quality Index	two consecutive nights	sleep-related questionnaire

Trial Locations

Locations (1)

Yueh-Ting Tsai; 🇨🇳 Taichung city, Taiwan