insomnia
Conditions
Interventions
Ramelteon intervention
Sponsors
Ayuse Takao
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-REM / REM sleep disorder incidence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence rate of circadian rhythm sleep disorder (occurrence rate of delayed sleep phase syndrome with sleepiness and strong malaise) | — |
Contacts
Public ContactTakao Ayuse
Nagasaki University Hospital
Outcome results
None listed