Evaluation of the Effect of Combined Music on Sleep Disorder | NCT05739773

Studies
Evaluation of the Effect of Combined Music on Sleep Disorder

NCT05739773

Sponsor

China Medical University, Taiwan

Status

Unknown status

Last Update Posted

Feb 22, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Sleep Disorder

Interventions

five-element music therapy

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CMUH110-REC1-170	Other Identifier	ChinaMUH

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2022Actual

Primary Completion Date

Aug 11, 2023Estimated

Completion Date

Oct 11, 2023Estimated

First Submitted Date

Nov 5, 2022

First Submission Date that Met QC Criteria

Feb 13, 2023

First Posted Date

Feb 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2023

Last Update Posted Date

Feb 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yueh-Ting Tsai, Assistant professor, China Medical University, TaiwanPrincipal Investigator

Lead Sponsor

China Medical University, TaiwanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study	Experimental	the five-element music group	Other: five-element music therapy
Control	Placebo Comparator	binaural beats group	Other: five-element music therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
five-element music therapy	Other	music therapy	Control Study

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Pittsburgh Sleep Quality Index	sleep-related questionnaire	two consecutive nights
Epworth Sleepiness Scale	sleep-related questionnaire

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yueh-Ting Tsai	Contact	0963675111		yuehting.tsai@gmail.com

Overall Officials

Name	Affiliation	Role
Yueh-Ting Tsai	China Medical University, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yueh-Ting Tsai	Recruiting	Taichung			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012893	Sleep Wake Disorders

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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