Clinical trial NCT05739773: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorder
Lead sponsor: China Medical University, Taiwan
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: polysomnography
timeFrame: two consecutive nights
measure: change meridian energy
timeFrame: two consecutive nights
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: two consecutive nights
measure: Epworth Sleepiness Scale
timeFrame: two consecutive nights
measure: Berlin Questionnaire
timeFrame: two consecutive nights
measure: Hospital Anxiety and Depression Scale
timeFrame: two consecutive nights
Other outcomes:
Locations:
city: Taichung city
country: Taiwan
facility: Yueh-Ting Tsai
Study officials:
affiliation: China Medical University, Taiwan
name: Yueh-Ting Tsai
role: PRINCIPAL_INVESTIGATOR
References: