NCT03276585

Brief Summary

The investigators hypothesized that depression is associated with home sleep EEG, subjective sleepiness and insomnia symptoms. To test this, the investigators plan to perform sleep examination with single channel EEG, in combination with questionnaire survey for insomnia, sleepiness, depression and job stress to Koka city government employees.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

September 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

September 3, 2017

Last Update Submit

April 19, 2018

Conditions

Sleep Initiation and Maintenance DisordersDepression

Keywords

home sleep monitorSleep Apnea Syndromesquestionnaire

Outcome Measures

Primary Outcomes (1)

  • Insomnia Severity Index (ISI)

    The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia.

    2 weeks

Secondary Outcomes (2)

  • Patient Health Questionnaire (PHQ-9)

    2 weeks

  • Epworth Sleepiness Scale (ESS)

    2 weeks

Other Outcomes (11)

  • Single-channel Electroencephalogram (EEG)

    1 week

  • Respiratory Event Index (REI)

    1 week

  • Chalder fatigue scale

    2 weeks

  • +8 more other outcomes

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Koka city government employees (Koka city, Shiga prefecture, Japan)

You may qualify if:

  • Koka city government employees (Koka city, Shiga prefecture, Japan)

You may not qualify if:

  • Subjects who need legally acceptable representative to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiga University of Medical Science

Ōtsu, Shiga, 520-2192, Japan

Location

Related Publications (1)

  • Omichi C, Kaminishi Y, Kadotani H, Sumi Y, Ubara A, Nishikawa K, Matsuda A, Ozeki Y. Limited social support is associated with depression, anxiety, and insomnia in a Japanese working population. Front Public Health. 2022 Nov 21;10:981592. doi: 10.3389/fpubh.2022.981592. eCollection 2022.

    PMID: 36483246DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepressionSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehaviorApneaRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Hiroshi Kadotani, MD,PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2017

First Posted

September 8, 2017

Study Start

September 6, 2017

Primary Completion

March 31, 2019

Study Completion

August 31, 2019

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

JP(1)