臨床研究等提出・公開システム

Date of registration	Mar. 12, 2024
Last modified on	Mar. 12, 2024
Trial ID	jRCT1060230108

Scientific Title	A study of factors contributing to the prevention of sleep problems in children with developmental disabilities.
Public Title	Research on the prevention of sleep problems in children with developmental disabilities.

Contact for Scientific Queries	Name	Honami Yamaguchi
	Affiliation	Shimane University
	Address	1060 Nishikawatu-cho, Matsue-shi, Shimae
	Telephone	+81-859-32-6266
	E-mail	yamaguchi.h@edu.shimane-u.ac.jp
Contact for Public Queries	Name	Honami Yamaguchi
	Affiliation	Shimane University
	Address	1060 Nishikawatu-cho, Matsue-shi, Shimae
	Telephone	+81-859-32-6266
	E-mail	yamaguchi.h@edu.shimane-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 12, 2024
Actual date of first enrollment		Mar. 07, 2024
Target sample size		40
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Are 4- and 5-year-old children at the start of the study 2) The child is using a child development support centre or office or other rehabilitation services
	Exclusion Criteria	1) A person whose age is 18 years or older 2) Who can agree to complete three questionnaires
	Age Minimum	4age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Developmental disability and suspected developmental disability
Health Condition(s) Keyword		sleep, survey, developmental disabilities
Health Condition(s) Code		D002658
Primary Outcome(s)		Changes in children's sleep questionnaire scores at two time points, Time1 and Time2 (6 months later).
Secondary Outcome(s)		Changes in sleep habits (FISH items) and sleep problems (Child Sleep Questionnaire) at time points T1, T2 and T3 as objective variables, SDQ (total and subscale scores), SRS-2 (T scores and subscale scores), ADHD-RS (total and subscale scores) and AIS total scores

Primary Sponsor	none

Secondary Sponsor

Name of Certified Review Board	Shimane University School of Medicine Medical Research Ethics Committee
Address	89-1 Enya-cho, Izumo-shi, Shimane, 693-8501 Japan, Shimane, Shimane, Shimane
Telephone	+81-853-20-2515
E-Mail	kenkyu@med.shimane-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 05, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none