UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053505 |
|---|---|
| Receipt number | R000061068 |
| Scientific Title | Effectiveness of mobile applications to Improve Insomnia Symptoms in Female Worker: A Systematic Review and Meta-Analyses |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/08/01 12:06:55 |
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Basic information
Public title
Effectiveness of mobile applications to Improve Insomnia Symptoms in Female Worker: A Systematic Review and Meta-Analyses
Acronym
Effectiveness of mobile applications to Improve Insomnia Symptoms in Female Worker: A Systematic Review and Meta-Analyses
Scientific Title
Effectiveness of mobile applications to Improve Insomnia Symptoms in Female Worker: A Systematic Review and Meta-Analyses
Scientific Title:Acronym
Effectiveness of mobile applications to Improve Insomnia Symptoms in Female Worker: A Systematic Review and Meta-Analyses
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify if mobile sleep applications can alleviate insomnia symptoms among adult females.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
insomnia symptoms
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. general population including women
2. those with insomnia symptoms
3. sleep digital application
Key exclusion criteria
1. other than original articles
2. those whose outcome is not insomnia symptoms
3. the subject is a child (less than 18 years) or older adult (more than 65 years)
4. the study is conducted on outpatients or inpatients
6. only male subjects
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Nomura |
Organization
Akita University
Division name
Department of Environmental Health Science and Public Health, Graduate School of Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita-shi, Akita
TEL
018-884-0687
knomura@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Songee |
| Middle name | |
| Last name | Jung |
Organization
Akita University
Division name
Department of Environmental Health Science and Public Health, Graduate School of Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita-shi, Akita
TEL
018-884-0688
Homepage URL
jonsoni@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Environmental Health Science and Public Health, Akita University Graduate School of Medicine
Address
1-1-1, Hondo, Akita-shi, Akita
Tel
018-884-6461
soken@hos.akita-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
| 2024 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10290
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 09 | Day |
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 | 03 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The systematic review has adhered to the guidelines in PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) for both the search process and reporting procedures. Electronic databases such as PubMed, Cochrane, PsycINFO, and Web of Science will be used.
Management information
Registered date
| 2024 | Year | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061068
