Insomnia disorder Insomnia disorder
Conditions
Sponsors
Ueno Taro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Insomnia disorder (ICSD-3). 2. Patients who can understand Japanese. 3. Patient who has smartphone.
Exclusion criteria
Exclusion criteria: 1. Patients with Athens Insomnia Scale (AIS) at the getting consent or beginning of the trial less than 9 points. 2. Patients who have experienced drug treatment for insomnia within the past 14 days. 3. Patients without a sleeping diary since 7 days from the start of the trial, or Patients who do not need further improvement. 4. Patients suspected or suffering from the following diseases. Mental illness Sleep apnea syndrome Sleep-related movement disorder Central hypersomnia Accompanying sleep Circadian rhythm disturbance alcoholism drug addiction cancer immune disease 5. Pregnant women, lactating women 6. Patients who are engaged in jobs requiring driving such as automobiles or motorbikes or jobs involving danger or scheduled to participate during the trial participation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Athens Insomnia Scale at 8 weeks from the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| CGI-I Percentage of patients with AIS of less than 6 points at completion of clinical trial medication after completion of clinical trial | — |
Contacts
Public ContactYosuke Watanabe
SUSMED, Inc
Outcome results
None listed