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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05739773
Other study ID # P11001
Secondary ID CMUH110-REC1-170
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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