臨床研究等提出・公開システム

Date of registration	June. 04, 2026
Last modified on	June. 04, 2026
Trial ID	jRCT1030260193

Scientific Title	Relationship Between Delayed Sleep-Wake Phase Disorder and Core Autism Symptoms in Adolescents with Autism Spectrum Disorder
Public Title	Relationship Between DSWPD and Core Autism Symptoms in Adolescents with ASD

Contact for Scientific Queries	Name	Fukunaga Hirotaka
	Affiliation	Shinshu University Graduate School
	Address	3-1-1 Asahi, Matsumoto, Nagano
	Telephone	+81-263-37-3117
	E-mail	hrxfukunaga@gmail.com
Contact for Public Queries	Name	Fukunaga Hirotaka
	Affiliation	Akita Prefectural Center on Development and Disability
	Address	1-1-2 Minamigaoka, Akita, Akita
	Telephone	+81-18-826-2401
	E-mail	hrxfukunaga@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 16, 2026
Actual date of first enrollment		Feb. 16, 2026
Target sample size		40
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	single blind
	control	uncontrolled control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Outpatients diagnosed with autism spectrum disorder (ASD) according to the diagnostic criteria of DSM-5-TR. 2. Individuals aged 12 years or older and younger than 19 years at time informed consent was obtained. 3. Individuals currently enrolled in junior high school or high school. 4. Individuals who are able to provide written informed consent themselves or whose parent(s) or legally authorized representative(s) are able to provide written informed consent for study participation.
	Exclusion Criteria	1. Individuals who are unable to discontinue hypnotic medications during the assessment period. 2. Individuals who are unable to wear the study measurement devices at home. 3. Individuals considered unsuitable for participation in the study by the principal investigator.
	Age Minimum	12age old over
	Age Maximum	19age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Autism Spectrum Disorder, Delayed Sleep-Wake Phase Disorder
Health Condition(s) Keyword		Autism Spectrum Disorder (ASD); Delayed Sleep-Wake Phase Disorder (DSWPD)
Health Condition(s) Code		F03.625.164.113, F03.870.400.200
Primary Outcome(s)		1. Difference in the Social Communication subscale score of the Social Responsiveness Scale, Second Edition (SRS-2) between participants with and without delayed sleep-wake phase disorder (DSWPD). 2. Difference in the Repetitive Behavior Scale-Revised (RBS-R) total score and the Restricted Interests and Repetitive Behavior subscale score of SRS-2 between participants with and without DSWPD.
Secondary Outcome(s)		Effects of the following variables on SRS-2 and RBS-R scores: 1. Presence or absence of DSWPD 2. Characteristics of circadian rhythm disturbance, including delayed circadian phase and severity of difficulty awakening 3. Sleep, behavioral, and physiological parameters measured and analyzed using wearable devices, including: Sleep parameters (e.g., total sleep time, sleep efficiency, sleep latency, wake after sleep onset, sleep stages) Rest-activity rhythm parameters (e.g., amplitude, phase, and circadian irregularity) Lifestyle-related activity patterns (e.g., total daily activity, meal timing, exercise, and activity patterns across different periods of the day) 4. Intelligence quotient (IQ) 5. Screen time

Primary Sponsor	No Sponsor

Secondary Sponsor

Name of Certified Review Board	Shinshu University School of Medicine Biological and Medical Research Ethics Committee
Address	3-1-1, Asahi, Matsumoto, Nagano
Telephone	+81-263-37-2572
E-Mail	mdrinri@shinshu-u.ac.jp
Approval Status	Approval
Date of approval	Aug. 19, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none