Double-blinded study of non-medication therapy with a software Yukumi in patients with insomnia disorders
- Conditions
- Insomnia disorder
- Registration Number
- JPRN-jRCT2032210071
- Lead Sponsor
- eno Taro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 156
1. Insomnia disorder (ICSD-3).
2. Patients who can understand Japanese.
3. Patient who has smartphone.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of Athens Insomnia Scale at 8 weeks from the start of treatment
- Secondary Outcome Measures
Name Time Method CGI-I<br>Percentage of patients with AIS of less than 6 points at completion of clinical trial<br>medication after completion of clinical trial