臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 11, 2020
Last modified on	June. 27, 2024
Trial ID	jRCT1071200030

Scientific Title	Study on the preventive effect of ramelteon on the onset of sleep disorder after general anesthesia in patients with autism spectrum disorder
Public Title	Study on the preventive effect of ramelteon on the onset of sleep disorder after general anesthesia in patients with autism spectrum disorder

Contact for Scientific Queries	Name	Ayuse Takao
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto Nagasaki Japan
	Telephone	+81-958197713
	E-mail	ayuse@nagasaki-u.ac.jp
Contact for Public Queries	Name	Ayuse Takao
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto Nagasaki Japan
	Telephone	+81-958197713
	E-mail	ayuse@nagasaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 11, 2020
Actual date of first enrollment		July. 30, 2021
Target sample size		90
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1)Age: Autism spectrum disorder patient who is between 12 years old and 60 years old at the time of obtaining consent 2)Patients who fullfill next criteria, 1: Patients who have already been diagnosed with insomnia and have been given oral treatment with drugs other than Rozerem. 2: Patients who have not been diagnosed with sleep disorders in the past, but are "probable insomnia" with a score of 4 to 5 on the Athens insomnia scale or "probable insomnia" with a score of 6 or more before admission to the hospital. 3)Patients without serious systemic complications (ASA PS I-II) 4)Gender: Any 5)Hospitalization/Outpatient: Hospitalization only 6)Patient's parents who, after receiving a sufficient explanation to participate in this study, gained a thorough understanding and obtained the informed consent of their parents.
	Exclusion Criteria	1)Patients already taking Rozerem 2)Lactating women 3)Patients with serious complications (ASA PSIII or higher) 4)Patients with a history of hypersensitivity to Rozerem 5)Patients with advanced liver dysfunction 6)Patients receiving fluvoxamine maleate 7)Other patients that the investigator judged to be inappropriate as the study subjects
	Age Minimum	12age old over
	Age Maximum	60age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		insomnia
Intervention(s)		Ramelteon intervention
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Non-REM / REM sleep disorder incidence rate
Secondary Outcome(s)		Occurrence rate of circadian rhythm sleep disorder (occurrence rate of delayed sleep phase syndrome with sleepiness and strong malaise)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nagasaki University Clinical Research Committee
Address	1-7-1 Sakamoto Nagasaki, Nagasaki
Telephone	+81-95-819-7229
E-Mail	gaibushikin@ml.nagasaki-u.ac.jp
Approval Status	Approval
Date of approval	July. 13, 2020

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	June. 27, 2024	(this page)	Changes
4	Sept. 07, 2023	Detail	Changes
3	Mar. 25, 2023	Detail	Changes
2	Mar. 26, 2021	Detail	Changes
1	Sept. 11, 2020	Detail

List of change history