Evaluation of the Effect of Combined Music on Sleep Disorder

Last updated: February 13, 2023
Sponsor: China Medical University, Taiwan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Sleep Disorders

Restless Leg Syndrome

Treatment

N/A

Clinical Study ID

NCT05739773
P11001
CMUH110-REC1-170
  • Ages 20-79
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • sleep disorder
  • PSQI score > 5

Exclusion

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

Total Participants: 60
Study Start date:
October 07, 2022
Estimated Completion Date:
October 11, 2023

Study 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).

Connect with a study center

  • Yueh-Ting Tsai

    Taichung city,
    Taiwan

    Active - Recruiting

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