UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042263 |
|---|---|
| Receipt number | R000046295 |
| Scientific Title | Randomized controlled trial to evaluate the effect of personalized message by smart phone for sleep quality. |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2021/08/23 18:17:31 |
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Basic information
Public title
Randomized controlled trial to evaluate the effect of personalized message by smart phone for sleep quality.
Acronym
Randomized controlled trial to evaluate the effect of personalized message by smart phone for sleep quality.
Scientific Title
Randomized controlled trial to evaluate the effect of personalized message by smart phone for sleep quality.
Scientific Title:Acronym
Randomized controlled trial to evaluate the effect of personalized message by smart phone for sleep quality.
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of behavioral therapy by smartphone application for sleep problem.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change of the Insomnia Severity Index at 4 weeks later.
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
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Use of Smartphone application which comprises sleep diary, personalized information of sleep hygiene guidance and sleep schedule method for 4 weeks.
Interventions/Control_2
No intervention
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Over 20 years old worker who feels sleep problem and has own smartphone with capability to make informed consent.
Key exclusion criteria
People who have unmatched smartphone for the application.
Shift workers.
People who have the schedule of overseas travelling during study period.
Scoring 10 or more on PHQ-9 and scoring 2 or 3 on item 9 of PHQ-9 at screening.
People who are assessed as unfit for the study by researchers.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University
Division name
Health service
Zip code
606-8501
Address
Yoshidahon-machi, Sakyo-ku, Kyoto
TEL
075-753-2401
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonari |
| Middle name | |
| Last name | Shimamoto |
Organization
Kyoto university
Division name
Health service
Zip code
606-8501
Address
Yoshidahon-machi, Sakyo-ku, Kyoto
TEL
075-753-2415
Homepage URL
sleepprompt_trial@hoken.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Health Service.
Institute
Department
Personal name
Funding Source
Organization
Healthtech labolatory Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
沖電気工業株式会社（東京都）、東和薬品株式会社（大阪）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 04 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 27 | Day |
Last modified on
| 2021 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046295
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
