NCT05739773

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

November 5, 2022

Last Update Submit

February 13, 2023

Conditions

Sleep Disorder

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • Pittsburgh Sleep Quality Index

    two consecutive nights

  • Epworth Sleepiness Scale

    two consecutive nights

  • Berlin Questionnaire

    two consecutive nights

  • Hospital Anxiety and Depression Scale

    two consecutive nights

Study Arms (2)

Study

EXPERIMENTAL

the five-element music group

Other: five-element music therapy

Control

PLACEBO COMPARATOR

binaural beats group

Other: five-element music therapy

Interventions

five-element music therapyOTHER

music therapy

Also known as: binaural beats
ControlStudy

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sleep disorder
  • PSQI score \> 5

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yueh-Ting Tsai

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Yueh-Ting Tsai

    China Medical University, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueh-Ting Tsai

CONTACT

0963675111yuehting.tsai@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 5, 2022

First Posted

February 22, 2023

Study Start

October 7, 2022

Primary Completion

August 11, 2023

Study Completion

October 11, 2023

Last Updated

February 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)