臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 26, 2024
Last modified on	Jan. 26, 2024
Trial ID	jRCT1050230171

Scientific Title	Effect of music appreciation before bedtime on worker's subjective sleep quality, daytime sleepiness and fatigue
Public Title	Effect of music appreciation before bedtime on worker's subjective sleep quality, daytime sleepiness and fatigue

Contact for Scientific Queries	Name	Shinohara Yasushi
	Affiliation	Biwako-Kusatsu Campus, Ritsumenkan University
	Address	1-1-1 Noji-higashi, Kusatsu Shiga
	Telephone	+81-77-599-4130
	E-mail	ysr15159@fc.ritsumei.ac.jp
Contact for Public Queries	Name	Shinohara Yasushi
	Affiliation	BIwako-Kusatsu Campus, Ritsumeikan University
	Address	1-1-1 Noji-higashi, Kusatsu Shiga
	Telephone	+81-77-599-4130
	E-mail	ysr15159@fc.ritsumei.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 26, 2024
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	crossover assignment
	purpose	health services research
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy individuals aged 20 to 65 who work full-time during the daytime on weekdays.
	Exclusion Criteria	Individuals who have subjective symptoms or treatments such as Narcolepsy, idiopathic hypersomnia, Kleine Levin Syndrome, circadian rhythm sleep disorder, sleep apnea syndrome, restless legs syndrome, periodic limb movement disorder, somnambulism, sleep terrors, REM sleep behavior disorder, mental illness, other sleep-disturbing symptoms, and hearing impairment. Those who take sleeping pills.
	Age Minimum	20age old over
	Age Maximum	65age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Improvement of sleep quality
Intervention(s)		We set control and intervention conditions and conduct a crossover trial. The control condition: Participants sleep as usual. The intervention condition: Participants appreciate music in 15 minutes before bedtime from Sunday to Thursday. In both conditions, subjects answer the following questionnaires on Monday, Wednesday, and Friday: OSA sleep inventory MA version when waking up, and Japanese version of the Epworth Sleepiness Scale and Jikaku-sho shirabe during the daytime. Participants answer pre-intervention questions during the informed consent process and post-intervention questions after completing the entire process.
Health Condition(s) Keyword		the quality of sleep
Intervention(s) Keyword		music appreciation
Health Condition(s) Code		D000089943
Intervention(s) Code		D009147
Primary Outcome(s)		The measurements are subjective feeling of sleep, daytime sleepiness, and fatigue. Questionnaires such as OSA sleep inventory MA version, Japanese version of the Epworth Sleepiness Scale, and Jikaku-sho shirabe that is a questionnaire to assess fatigue are used.
Secondary Outcome(s)		The following questions are asked to understand the attributes of the research subjects and gather information on their music appreciation habits and impressions of the music. Before intervention Age, sex, past medical history, the presence of taking sleep medicine, the presence of habits of music appreciation before bedtime, sleep duration on weekdays, subjective sleep quality, and any additional comments or concerns. After intervention Partcipant's impressions of the music and any additional comments or concerns.

Primary Sponsor	College of Sport and Health Science, Ritsumeikan University

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Ethics Review Committee for Medical Research Involving Human Subjects in Ritsumeikan University
Address	1-1-1 Noji-higashi, Kusatsu Shiga, Shiga
Telephone	+81-77-599-4175
E-Mail	b-rinri@st.ritsumei.ac.jp
Approval Status	Approval
Date of approval	Mar. 08, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none