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Evaluation of the Effect of Combined Music on Sleep Disorder

Primary Purpose

Sleep Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
five-element music therapy
Sponsored by
China Medical University, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yueh-Ting TsaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study

Control

Arm Description

the five-element music group

binaural beats group

Outcomes

Primary Outcome Measures

polysomnography
Polysomnography refers to a systematic process used to collect physiologic parameters during sleep
change meridian energy
Meridian energy examination

Secondary Outcome Measures

Pittsburgh Sleep Quality Index
sleep-related questionnaire
Epworth Sleepiness Scale
sleep-related questionnaire
Berlin Questionnaire
sleep-related questionnaire
Hospital Anxiety and Depression Scale
sleep-related questionnaires

Full Information

First Posted
November 5, 2022
Last Updated
February 13, 2023
Sponsor
China Medical University, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05739773
Brief Title
Evaluation of the Effect of Combined Music on Sleep Disorder
Official Title
Evaluation of the Effect of Five Elements Music Combined With Binaural Beat on Sleep Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
August 11, 2023 (Anticipated)
Study Completion Date
October 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study
Arm Type
Experimental
Arm Description
the five-element music group
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
binaural beats group
Intervention Type
Other
Intervention Name(s)
five-element music therapy
Other Intervention Name(s)
binaural beats
Intervention Description
music therapy
Primary Outcome Measure Information:
Title
polysomnography
Description
Polysomnography refers to a systematic process used to collect physiologic parameters during sleep
Time Frame
two consecutive nights
Title
change meridian energy
Description
Meridian energy examination
Time Frame
two consecutive nights
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
sleep-related questionnaire
Time Frame
two consecutive nights
Title
Epworth Sleepiness Scale
Description
sleep-related questionnaire
Time Frame
two consecutive nights
Title
Berlin Questionnaire
Description
sleep-related questionnaire
Time Frame
two consecutive nights
Title
Hospital Anxiety and Depression Scale
Description
sleep-related questionnaires
Time Frame
two consecutive nights

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yueh-Ting Tsai
Phone
0963675111
Email
yuehting.tsai@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yueh-Ting Tsai
Organizational Affiliation
China Medical University, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yueh-Ting Tsai
City
Taichung city
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yueh-Ting Tsai
Phone
0963675111
Email
yuehting.tsai@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of the Effect of Combined Music on Sleep Disorder

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