JPRN-jRCT2032200101CompletedPhase 2
Sham (software)-controlled, multicenter, dynamic allocation, double-blinded study of non-medication therapy with a software Yukumi in patients with insomnia disorders
eno Taro0 sites40 target enrollmentStarted: August 31, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1. Insomnia disorder (ICSD-3).
- •2. Patients who can understand Japanese.
- •3. Patient who has smartphone.
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
- •drug addiction
- •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.
Investigators
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