Evaluation of the Effect of Combined Music on Sleep Disorder

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder
• Intervention / Treatment: Other: five-element music therapy

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueh-Ting Tsai; Phone Number: 0963675111; Email: yuehting.tsai@gmail.com

Study Locations

• Taiwan
  • Taichung city, Taiwan
    • Recruiting
    • Yueh-Ting Tsai
    • Contact: Yueh-Ting Tsai; Phone Number: 0963675111; Email: yuehting.tsai@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study; the five-element music group	Other: five-element music therapy; music therapy; Other Names: binaural beats
Placebo Comparator: Control; binaural beats group	Other: five-element music therapy; music therapy; Other Names: binaural beats

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China Medical University, Taiwan
• Investigators: Principal Investigator: Yueh-Ting Tsai, China Medical University, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Anticipated): August 11, 2023
• Study Completion (Anticipated): October 11, 2023

Study Registration Dates

• First Submitted: November 5, 2022
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Estimate): February 22, 2023

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: P11001; CMUH110-REC1-170 (Other Identifier: ChinaMUH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No