UMIN-CTR Clinical Trial

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028675
Receipt No. 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 (Ver. 12)

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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
Email 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
Email hqsuimin@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science, Department of Sleep and Behavioral Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032827