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

JRCT ID: jRCT1071200030

Registered date:11/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: insomnia
• Date of first enrollment: 30/07/2021
• Target sample size: 90
• Study type: Interventional
• Intervention(s): Ramelteon intervention

Outcome(s)

• Primary Outcome: Non-REM / REM sleep disorder incidence rate
• Secondary Outcome: Occurrence rate of circadian rhythm sleep disorder (occurrence rate of delayed sleep phase syndrome with sleepiness and strong malaise)

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 60age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Ayuse Takao