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Evaluation of the Effect of Combined Music on Sleep Disorder

Evaluation of the Effect of Five Elements Music Combined With Binaural Beat on Sleep Disorder

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05739773
Enrollment
60
Registered
2023-02-22
Start date
2022-10-07
Completion date
2023-10-11
Last updated
2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorder

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).

Interventions

OTHERfive-element music therapy

music therapy

Sponsors

China Medical University, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
polysomnographytwo consecutive nightsPolysomnography refers to a systematic process used to collect physiologic parameters during sleep
change meridian energytwo consecutive nightsMeridian energy examination

Secondary

MeasureTime frameDescription
Pittsburgh Sleep Quality Indextwo consecutive nightssleep-related questionnaire
Epworth Sleepiness Scaletwo consecutive nightssleep-related questionnaire
Berlin Questionnairetwo consecutive nightssleep-related questionnaire
Hospital Anxiety and Depression Scaletwo consecutive nightssleep-related questionnaires

Countries

Taiwan

Contacts

Primary ContactYueh-Ting Tsai
yuehting.tsai@gmail.com0963675111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026