UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042263
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email sleepprompt_trial@hoken.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Health Service.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046295

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.