Evaluation of the Effect of Combined Music on Sleep Disorder

NCT ID: NCT05739773

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-07
• Study Completion Date: 2023-10-11

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).

Conditions

Sleep Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study

the five-element music group

Group Type: EXPERIMENTAL

five-element music therapy

Intervention Type: OTHER

music therapy

Control

binaural beats group

Group Type: PLACEBO_COMPARATOR

five-element music therapy

Intervention Type: OTHER

music therapy

Interventions

five-element music therapy

music therapy

Intervention Type: OTHER

Other Intervention Names

binaural beats

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Yueh-Ting Tsai

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yueh-Ting Tsai

Role: PRINCIPAL_INVESTIGATOR

China Medical University, Taiwan

Locations

Yueh-Ting Tsai

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yueh-Ting Tsai

Role: CONTACT

yuehting.tsai@gmail.com

0963675111

Facility Contacts

Yueh-Ting Tsai

Role: primary

yuehting.tsai@gmail.com

0963675111

Other Identifiers

CMUH110-REC1-170

Identifier Type: OTHER

Identifier Source: secondary_id

P11001

Identifier Type: -

Identifier Source: org_study_id