UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050353 |
|---|---|
| Receipt number | R000057317 |
| Scientific Title | Effectiveness of sleep habit enhanced application on insomnia and depression. |
| Date of disclosure of the study information | 2023/02/15 |
| Last modified on | 2023/02/17 00:01:41 |
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Basic information
Public title
Effectiveness of sleep habit enhanced application on insomnia and depression.
Acronym
Effectiveness of sleep habit enhanced application
Scientific Title
Effectiveness of sleep habit enhanced application on insomnia and depression.
Scientific Title:Acronym
Effectiveness of sleep habit enhanced application
Region
| Japan |
Condition
Condition
insomnia, depression
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of an application that enables assessment of an individual's lifestyle (Sleep Habit Improvement Application), which was researched and developed to realize an individualized intervention using the Cognitive Behavioral Therapy for Insomnia (CBT-I) tool, was verified, showing the same level of effectiveness as individual counseling.
In this study, we will classify the groups into experimental group (insomnia-only group, depression-only group, and comorbidity group) and comparison group (healthy group), and verify whether the reduction of anxiety and depression symptoms by this application reaches the healthy level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Athens Insomnia Scale (pre- and post-intervention, and 1-month and 3-month follow-up)
Key secondary outcomes
K6, Sheehan Disability Scale, ESS, and HPQ (pre- and post-intervention, and 1-month and 3-month follow-up)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
individuals with insomnia
Interventions/Control_2
individuals with depression
Interventions/Control_3
insomnia comorbid with depression
Interventions/Control_4
healthy adults
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adults over 20 years old
2. Adults who are interested in improving their sleep
Key exclusion criteria
none
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Jou |
| Middle name | |
| Last name | Akitomi |
Organization
NEC Solution Innovators Ltd.
Division name
Innovation Promotion Division
Zip code
136-0082
Address
1-18-7 Shinkiba, Taito-ku, Tokyo
TEL
03-5534-2222
akitomi-jou@nec.com
Public contact
Name of contact person
| 1st name | Jou |
| Middle name | |
| Last name | Akitomi |
Organization
NEC Solution Innovators Ltd.
Division name
Innovation Promotion Division
Zip code
136-0082
Address
1-18-7 Shinkiba, Taito-ku, Tokyo
TEL
03-5534-2222
Homepage URL
akitmi-jou@nec.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
NEC Solution Innovators Ltd
Address
1-18-7 Shinkiba, Taito-ku, Tokyo
Tel
03-5534-2222
akitomi-jou@nec.com
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
| 2023 | Year | 02 | 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
832
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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 17 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057317
| Research Plan | |
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| 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 |
