Study on the preventive effect of ramelteon on the onset of sleep disorder after general anesthesia in patients with autism spectrum disorder
- Conditions
- insomnia
- Registration Number
- JPRN-jRCT1071200030
- Lead Sponsor
- Ayuse Takao
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method