UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028675 |
|---|---|
| Receipt number | R000032827 |
| Scientific Title | Epidemiological Study on Insomnia and Depression Using Home Sleep Monitors in a Japanese Rural City Population |
| Date of disclosure of the study information | 2017/09/10 |
| Last modified on | 2020/09/01 11:49:56 |
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Basic information
Public title
Epidemiological Study on Insomnia and Depression Using Home Sleep Monitors in a Japanese Rural City Population
Acronym
Night in Japan Home Sleep Monitoring Study (NinJaSleep Study)
Scientific Title
Epidemiological Study on Insomnia and Depression Using Home Sleep Monitors in a Japanese Rural City Population
Scientific Title:Acronym
Night in Japan Home Sleep Monitoring Study (NinJaSleep Study)
Region
| Japan |
Condition
Condition
insomnia and depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Association between sleepiness and insomnia (subjective sleepiness, insomnia severity index, sleep drug use, and home EEG results such as sleep latency, sleep efficiency and EEG delta power)
Basic objectives2
Others
Basic objectives -Others
association study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
insomnia severity index (ISI)
Key secondary outcomes
Questinnaire survey (sleepiness (ESS), insomnia (ISI, FIRST-J), depression (PHQ-9), anxiety (GAD-7), fatigue (Chalder Fatigue Scale), Work Performance (WPQ)), home EEG (sleep latency, sleep efficiency and EEG delta power), home sleep apnea testing, annual examination data (cholesterols, blood sugar, blood pressure, BMI. etc.)
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Koka city government employees (Koka city, Shiga prefecture, Japan)
Key exclusion criteria
Subjects who need legally acceptable representative to consent.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kadotani |
Organization
Shiga University of Medical Science
Division name
Department of Sleep and Behavioral Sciences
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu City, Shiga, 520-2192 JAPAN
TEL
077-548-3632
hqsuimin@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kadotani |
Organization
Shiga University of Medical Science
Division name
Department of Sleep and Behavioral Sciences
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu City, Shiga, 520-2192 JAPAN
TEL
077-548-3632
Homepage URL
hqsuimin@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science, Department of Sleep and Behavioral Sciences
Institute
Department
Personal name
Funding Source
Organization
Merck Sharp & Dohme Corp./MSD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Koka city
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu City, Shiga, 520-2192 JAPAN
Tel
077-548-2010
hqbunsho@belle.shiga-med.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
| 2017 | Year | 09 | Month | 10 | 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
A part of questionnaire survey result was published in Sleep Science and Practice 2018 2:4(https://doi.org/10.1186/s41606-018-0024-0).
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 02 | Month | 28 | Day |
Other
Other related information
Primary objective:
1. Association between sleepiness and insomnia (subjective sleepiness, insomnia severity index, sleep drug use, and home EEG results such as sleep latency, sleep efficiency and EEG delta power)
Secondary objectives:
2. Prevalence of insomnia and depression in a Japanese population.
3. Association between job stress and insomnia/depression
Exploratory objective:
4. Association between depression and sleepiness/insomnia
2.1.1 List the clinical hypotheses.
1. Depression is associated with home sleep monitoring results, subjective sleepiness and subjective insomnia symptoms.
2. Estimation study
3. Job stress is associated with depression and insomnia.
Management information
Registered date
| 2017 | Year | 08 | Month | 15 | Day |
Last modified on
| 2020 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032827
| 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 |
