UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061344 |
|---|---|
| Receipt number | R000068528 |
| Scientific Title | Efficacy of digital brief behavioral treatment for insomnia using a smartphone application, with or without adjunctive light therapy, in individuals with insomnia symptoms and late chronotypes: a three-arm randomized controlled trial |
| Date of disclosure of the study information | 2026/04/21 |
| Last modified on | 2026/04/21 17:56:38 |
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Basic information
Public title
Efficacy of digital brief behavioral treatment for insomnia using a smartphone application, with or without adjunctive light therapy, in individuals with insomnia symptoms and late chronotypes: a three-arm randomized controlled trial
Acronym
SKUSH-3way trial
Scientific Title
Efficacy of digital brief behavioral treatment for insomnia using a smartphone application, with or without adjunctive light therapy, in individuals with insomnia symptoms and late chronotypes: a three-arm randomized controlled trial
Scientific Title:Acronym
SKUSH-3way trial
Region
| Japan |
Condition
Condition
sleep disturbance
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether digital brief behavioral treatment for insomnia using a smartphone application, with or without adjunctive light therapy, can improve sleep and mental health in individuals with insomnia symptoms and late chronotypes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the Insomnia Severity Index (ISI) in the digital brief behavioral treatment for insomnia using a smartphone application alone group during the four-week intervention
Key secondary outcomes
Changes in the Insomnia Severity Index (ISI) were assessed in the digital BBT-I conjunction with light therapy group at pretest, weeks 1-4, and posttest. For both the digital BBT-I alone group and the digital BBT-I conjunction with light therapy group, changes from baseline to posttest and from baseline to follow-up were examined in the following outcomes: sleep onset time, wake-up time, time in bed, total sleep time, sleep onset latency, wake after sleep onset, time to get out of bed, sleep efficiency, bedtime, rise time, mid-sleep time, degree of sleep insufficiency, Morningness-Eveningness Questionnaire (MEQ) score, RU-SATED score, Epworth Sleepiness Scale (ESS) score, Patient Health Questionnaire-9 (PHQ-9) score, composite measures of sleep health score, social jetlag, and knowledge of sleep.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. Digital brief behavioral treatment for insomnia
Intervention using the sleep improvement app Sleep Healthy.
(i) Sleep schedule for phase advance
After the second week, the sleep phase was advanced. The application individually notified participants of their target bedtime for that day and their target wake up time for the next morning.
(ii) Sleep education
The application provided education for improving sleep through columns, videos, and sleep quizzes.
(iii) Recording a sleep diary
Participants input information such as bedtime and wake up time. Based on the entered data, feedback was provided on scores such as bedtime, actual sleep time, sleep efficiency, and mid sleep time.
2. Light therapy
Thirty minutes of light therapy after waking up.
3. Sleep recording
All participants recorded their activity during the night while the lights were off using the FS-770.
Interventions/Control_2
1. Digital brief behavioral treatment for insomnia
Intervention using the sleep improvement app Sleep Healthy.
(i) Sleep schedule for phase advance
After the second week, the sleep phase was advanced. The application individually notified participants of their target bedtime for that day and their target wake up time for the next morning.
(ii) Sleep education
The application provided education for improving sleep through columns, videos, and sleep quizzes.
(iii) Recording a sleep diary
Participants input information such as bedtime and wake up time. Based on the entered data, feedback was provided on scores such as bedtime, actual sleep time, sleep efficiency, and mid sleep time.
2. Sleep recording
All participants recorded their activity during the night while the lights were off using the FS-770.
Interventions/Control_3
Control
1. Sleep recording
All participants recorded their activity during the night while the lights were off using the FS-770.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals who fall under "definite evening type" or "moderate evening type," defined as having a Morningness-Eveningness Questionnaire (MEQ) score between 16 and 41
2. Individuals with an Insomnia Severity Index (ISI) score of 8 or higher
3. Individuals aged 18 years or older but younger than 40 years at the time of consent
4. Individuals who own a smartphone with a version and model compatible with the application
5. Individuals whose first language is Japanese
Key exclusion criteria
1. Individuals whose difference between current average wake-up time and target wake-up time exceeds 5 hours
2. Individuals who may experience significant time zone changes during the study period such as overseas travel
Rationale: improvement through intervention is not expected
3. Individuals engaged in shift work or night work
4. Individuals with the following comorbid conditions:
A. Those with photosensitivity
B. Those with severe past medical history
C. Those currently receiving treatment for insomnia or other sleep disorders
D. Those undergoing outpatient treatment in psychosomatic medicine or psychiatry
E. Individuals whose response frequency to Question 9 of the Patient Health Questionnaire-9 (PHQ-9)"Better off dead or thoughts of hurting yourself in some way" is "more than half the days" in the past two weeks
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Furihata |
Organization
Kyoto University
Division name
Agency for Student Support and Disability Resources
Zip code
6068501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2428
furihata.ryuji.2x@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoe |
| Middle name | |
| Last name | Okabayashi |
Organization
Kyoto university
Division name
Agency for Health, Safety and Environment
Zip code
6068501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2407
Homepage URL
skush.threeway@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Furihata Ryuji
Funding Source
Organization
This work was supported by JSPS KAKENHI Grant Number JP25K14911.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate school and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学（京都府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068528
