UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053877 |
|---|---|
| Receipt number | R000059468 |
| Scientific Title | A study of the effects of sleep behavior therapy using a sleep improvement app and light therapy on improving sleep problems in a night person : a pilot randomized controlled trial. |
| Date of disclosure of the study information | 2024/03/15 |
| Last modified on | 2024/03/15 22:15:41 |
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Basic information
Public title
A study of the efficacy of sleep behavior therapy using a sleep improvement app combined with light therapy to improve sleep problems in evening-type individuals: a pilot randomized controlled trial
Acronym
SKUSH-light trial
Scientific Title
A study of the effects of sleep behavior therapy using a sleep improvement app and light therapy on improving sleep problems in a night person : a pilot randomized controlled trial.
Scientific Title:Acronym
SKUSH-light study
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 verify whether the combination of sleep behavior therapy via a sleep improvement app and light therapy can improve the subjective sleep and mental health of evening-type individuals.
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) during the four weeks intervention
Key secondary outcomes
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
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sleep behavior therapy program
1.Sleep behavior therapy
Intervention through the Sleep Healthy sleep improvement app.
Send the following information daily by the app.
(i) Recording a sleep diary.
Input information such as bedtime and wake-up time. Based on the data entered, feedback is given on scores such as bedtime, actual sleep time, sleep efficiency and median sleep time.
(ii) Sleep schedule to advance sleep phases.
A sleep schedule is formulated using the app, and sleep behavior therapy is implemented to advance the waking and sleeping times by 30 minutes per day on weekdays and maintain the same rhythm on weekends.
(iii) Information about sleeping.
Provide information through columns, videos and quizzes.
(iv) Stimulus control and progressive muscle relaxation methods
Provide information through columns, videos and quizzes.
2.Light therapy
30 minutes of light therapy after waking up.
Interventions/Control_2
Not provide a remote Sleep behavior therapy program.
Only recording sleep with portable activity monitor.
Interventions/Control_3
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
| 39 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. MEQ9 score of 16 or above and 41 or below.
2. ISI10 score of 8 or more.
3. Aged between 18 and 39.
4. A person who owns his/her own smartphone.
5. A person whose first language is Japanese
6. Smartphone's version and model are compatible with the application.
Key exclusion criteria
1.Those for whom no improvement can be expected from the intervention
Those with a time difference of more than 5 hours between their current average wake-up time and their target wake-up time.
2.Those who will be in significant time differences, such as overseas travel, during the study period.
3.Shift Workers
4.Those for which the safety of the intervention cannot be guaranteed.
Photosensitivity.
Having a serious preexisting condition.
Those who has a treatment for sleep disorders.
Those who has a treatment in psychiatry.
Patient Health Questionnaire-9 (PHQ-9), Q9 "Thoughts that you would be better off dead or of hurting yourself in some way" is More than half the days in the past two weeks.
Target sample size
30
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 | Yukako |
| Middle name | |
| Last name | Nakagami |
Organization
Kyoto university
Division name
Agency for Student Support and Disability Resources
Zip code
6068501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2429
Homepage URL
skush.light@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Furihata Ryuji
Funding Source
Organization
Nishikawa Foundation for Medical Promotion, Terumo life science foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2024 | Year | 03 | Month | 15 | 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
28
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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 13 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 21 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059468
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