臨床研究等提出・公開システム

Date of registration	July. 01, 2020
Last modified on	Aug. 06, 2025
Trial ID	jRCT1030200061

Scientific Title	Effect of LED light using violet excitation peak on melatonin suppression
Public Title	Effect of LED light using violet excitation peak on melatonin suppression

Completion date	Dec. 07, 2020
Result actual enrolment	16
Baseline Characteristics	16 participants (16 males) were enrolled.
Participant flow	In the first session, the participants were randomly assigned to 2 groups, the violet-excitation LED group or the blue-excitation LED group. Then, in the second session, the partici- pants were assigned to the other intervention after a washout period. 1 participant was dropped out due to not coming to the test site.
Adverse events	No adverse events were observed.
Outcome measures	The overall melatonin suppression by violet-excitation LEDs was significantly smaller than that by blue-excitation LEDs. No significant differences in psychomotor vigilance and sleepiness were observed between the 2 groups.
Brief summary	Melatonin suppression in the group exposed to the violet-excitation LED was significantly smaller than that in the group exposed to the blue-excitation LED.
Date of the first journal publication of results	Jan. 01, 2024
URL hyperlink(s) related to results and publications	https://jcsm.aasm.org/doi/10.5664/jcsm.10814

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1030200061

Contact for Scientific Queries	Name	Mitsui Katsuhiro
	Affiliation	KYOCERA Corporation
	Address	800 Ichimiyake, Yasu-shi, Shiga 520-2362 Japan
	Telephone	+81-775878800
	E-mail	katsuhiro.mitsui.yb@kyocera.jp
Contact for Public Queries	Name	Mitsui Katsuhiro
	Affiliation	KYOCERA Corporation
	Address	800 Ichimiyake, Yasu-shi, Shiga 520-2362 Japan
	Telephone	+81-80-6234-7334
	E-mail	katsuhiro.mitsui.yb@kyocera.jp

Recruitment status	Complete

Anticipated date of first enrollment		June. 20, 2020
Actual date of first enrollment		June. 22, 2020
Target sample size		16
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	crossover assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	male, 20=< age <=39
	Exclusion Criteria	PSQI (Pittsburgh Sleep Quality Index) > 5, MEQ (Morningness Eveningness Questionnaire) <= 30 or MEQ >= 70, mental disease patient, eye disease patient, participants who need dental treatment
	Age Minimum	20age old over
	Age Maximum	39age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		healthy person
Intervention(s)		Polychromatic LED light using violet excitation peak (3 hour exposure) and Polychromatic LED light using blue excitation peak (3 hour exposure).
Primary Outcome(s)		Concentration of saliva melatonin
Secondary Outcome(s)		Psychomotor vigilance task, Karolinska Sleepiness Scale

Name of Certified Review Board	The Japanese Society for Wellbeing Science and Assistive Technology
Address	2-13-8 Torikoshi, Taito-ku, Tokyo
Telephone	+81-3-5809-1933
E-Mail	wsat@jswsat.org
Approval Status	Approval
Date of approval	Mar. 30, 2020

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Aug. 06, 2025	(this page)	Changes
2	Aug. 04, 2020	Detail	Changes
1	July. 01, 2020	Detail

List of change history