Evaluation of the Effect of Combined Music on Sleep Disorder

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739773
• Other study ID #: P11001
• Secondary ID: CMUH110-REC1-170
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: October 11, 2023

Study information

• Verified date: February 2023
• Source: China Medical University, Taiwan
• Contact: Yueh-Ting Tsai
• Phone: 0963675111
• Email: yuehting.tsai[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 11, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• five-element music therapy
music therapy

Locations

Country	Name	City	State
Taiwan	Yueh-Ting Tsai	Taichung city

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	polysomnography	Polysomnography refers to a systematic process used to collect physiologic parameters during sleep	two consecutive nights
Primary	change meridian energy	Meridian energy examination	two consecutive nights
Secondary	Pittsburgh Sleep Quality Index	sleep-related questionnaire	two consecutive nights
Secondary	Epworth Sleepiness Scale	sleep-related questionnaire	two consecutive nights
Secondary	Berlin Questionnaire	sleep-related questionnaire	two consecutive nights
Secondary	Hospital Anxiety and Depression Scale	sleep-related questionnaires	two consecutive nights