UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042634 |
|---|---|
| Receipt number | R000048092 |
| Scientific Title | A study of the effects of sleep behavioral therapy for social jet lag using a remote support system |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2023/03/05 11:13:52 |
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Basic information
Public title
A study of the effects of sleep behavioral therapy for social jetlag using a remote support system
Acronym
SKUSH trial
Scientific Title
A study of the effects of sleep behavioral therapy for social jet lag using a remote support system
Scientific Title:Acronym
SKUSH 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 investigate whether sleep behavioral therapy using a remote support system contributes to improved SJL in university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of SJL after 2 weeks intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Remote support system interventions: sleep behavioral therapy program based on 1.sleep hygiene education, 2.sleep extension.
Send the following information daily by email.
1. Sleep hygiene education
Instruction will be based on the sleep guidelines 2014, including appropriate sleep environment, exposure to sunlight after waking, limiting alcohol consumption and smoking before bedtime, limiting caffeinated beverage consumption, advice on diet, exercise and bathing, advice on blue light before bed, and advice on napping.
2. Sleep extension
Develop a sleep schedule based on the baseline survey and provide instruction on extending sleep to advance weekday bedtimes by 5 minutes per day. On weekends, provide instruction on waking up at the same time as weekdays to prevent late bedtime.
Interventions/Control_2
Not provide a remote support system programs
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese university and graduate school students
2. SJL is more than 60 minutes
3. Those who have own smartphone or computer with internet access
4. Those who speak Japanese as first langurage
5. Those who understand the research and obtain written consent to participate in the research
Key exclusion criteria
1. Shift Workers
2. Those who will be in significant time differences, such as overseas travel, during the study period
3. 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, or the total score is 10 or more
4. Those who has a treatment in psychiatry
5. Taking antidepressant medication
6. Those who the researcher think it is inappropriate to enter study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Furihata |
Organization
Kyoto University
Division name
Kyoto University Health Service
Zip code
6068501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2404
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
Kyoto University Health Service
Zip code
6068501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2404
Homepage URL
sleephealth_trial@hoken.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Health Service
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kyoto University
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://yobou.med.kyoto-u.ac.jp/implementation/
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s41105-023-00453-5
Number of participants that the trial has enrolled
54
Results
Of 54 students, 26 were assigned to an intervention group and 28 to a control group. The difference in the mean change in social jetlag (SJL) between the two groups (n = 26, n = 27) at two weeks was statistically significant (27.7 min, P = 0.048). The scores for the Epworth Sleepiness Scale (ESS), Patient Health Questionnaire-9 (PHQ-9), and sleep quiz were improved in the intervention group relative to the control group.
Results date posted
| 2023 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 02 | Month | 21 | Day |
Baseline Characteristics
The percentage of obese (BMI>=25) individuals differed significantly between the two groups (X2=4.65, P=0.034), as did the percentage of individuals who consumed caffeine (X2=5.31, P=0.021).
Participant flow
Of the 210 individuals who applied to participate, 71 met the inclusion criteria on screening, and 139 did not meet the inclusion criteria. Sixty-nine were eligible to participate in the trial briefing information session (excluding 2 who canceled their participation). Among these individuals, 54 were eligible for allocation (excluding 7 who could not attend the trial briefing session, 6 who declined to participate in the briefing session, and 2 who canceled the trial attendance before randomization). Of those remaining, 26 were assigned to the intervention group and 28 to the control group. One participant in the control group was excluded from the analysis due to poor adherence. Thus, a total of 26 participants in the intervention group and 27 in the control group completed the trial. Finally, 22 participants in the intervention group and 27 in the control group completed the 6-month follow-up survey.
Adverse events
No important harmful or unintended effects were observed in either group.
Outcome measures
The primary measure
The mean change in social jetlag (SJL) assessed using the Munich ChronoType Questionnaire (MCTQ) from pre-test to post-test.
Secondary measures
Pittsburgh Sleep Quality Index (PSQI)
Epworth Sleepiness Scale (ESS)
Insomnia Severity Index (ISI)
Patient Health Questionnaire-9 (PHQ-9)
Sleep quiz
Sleep diary
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048092
