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Cross-sectional Study on Insomnia and Depression Using Home Sleep Monitors (KokaSleep)

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ClinicalTrials.gov Identifier: NCT03276585
Recruitment Status : Not yet recruiting
First Posted : September 8, 2017
Last Update Posted : September 8, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Sleep Initiation and Maintenance Disorders Depression

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Epidemiological Study on Insomnia and Depression Using Home Sleep Monitors in a Japanese Rural City Population
Anticipated Study Start Date : September 10, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : August 31, 2019
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-9) [ Time Frame: 2 weeks ]
    PHQ-9 is a 9-item self-administrated questionnaire, which assess Major depressive disorder.

  2. Epworth Sleepiness Scale (ESS) [ Time Frame: 2 weeks ]
    ESS is a 8-item self-administrated questionnaire, which assess the sleepiness.


Other Outcome Measures:
  1. Single-channel Electroencephalogram (EEG) [ Time Frame: 1 week ]
    Single-channel Electroencephalogram (EEG) can be used to analyze sleep latency, sleep efficiency and delta wave power at home. Sleep latency is the amount of time it takes to fall asleep after the lights have been turned off. Sleep efficiency is ratio of total sleep time to time in bed. EEG delta wave power is used as an index of the hypothetical sleep 'pressure' that has accumulated during wakefulness.

  2. Respiratory Event Index (REI) [ Time Frame: 1 week ]
    REI (numbers of apneas and hyponeas divided by recorded hours with home sleep testings), is used for diagnosis and severity definition of sleep apnea syndrome.

  3. Chalder fatigue scale [ Time Frame: 2 weeks ]
    Chalder fatigue scale is a self-rating score, which is now widely used to measure the severity of 'tiredness'.

  4. General Anxiety Disorder-7 (GAD-7) [ Time Frame: 2 weeks ]
    GAD-7 is a 7-item self-administrated questionnaire, which assess generalized anxiety disorder.

  5. FIRST (Ford Insomnia Response to Stress Test) [ Time Frame: 2 weeks ]
    FIRST is a 9-item self-rating score measuring the likelihood of the occurrence of sleep disturbances in response to commonly experienced stressful situations.

  6. 8-Item Short-Form Health Survey (SF-8) [ Time Frame: 1 month ]
    The SF-8 is an 8-item self-administrated questionnaire, which assess health-related quality of life.

  7. WHO Health and Work Performance Questionnaire (WHO-HPQ) [ Time Frame: 1 month ]
    WHO-HPQ is a self-report instrument designed to estimate the workplace costs of health problems in terms of self-reported sickness absence (absenteeism) and reduced job performance (presenteeism).

  8. The Brief Job Stress Questionnaire [ Time Frame: 1 month ]
    The Brief Job Stress Questionnaire is a 57-item self-administrated questionnaire, which assess stress in workplace. Japanese government launched the Stress Check Program in 2015. The program recommends to use the Brief Job Stress Questionnaire for defining "high-stress" workers.

  9. Athens Insomnia Scale (AIS) [ Time Frame: 1 month ]
    AIS is an 8-item self-administrated questionnaire, which assess Insomnia.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Koka city government employees (Koka city, Shiga prefecture, Japan)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects who need legally acceptable representative to consent.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276585


Contacts
Contact: Hiroshi Kadotnai, MD,PhD +81-77-548-3632 hqsuimin@belle.shiga-med.ac.jp
Contact: Taeko Toyoda +81-77-548-3632 toyod@belle.shiga-med.ac.jp

Locations
Japan
Shiga University of Medical Science
Otsu, Shiga, Japan, 520-2192
Sponsors and Collaborators
Shiga University
Merck Sharp & Dohme Corp.
Koka city
Investigators
Principal Investigator: Hiroshi Kadotani, MD,PhD Department of Sleep and Behavioral Sciences, Shiga University of Medical Science
More Information

Responsible Party: Shiga University
ClinicalTrials.gov Identifier: NCT03276585     History of Changes
Other Study ID Numbers: 29-111
UMIN000028675 ( Registry Identifier: UMIN Clinical Trials Registry (UMIN-CTR), Japan )
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We have not decided with whom to collaborate.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shiga University:
home sleep monitor
Sleep Apnea Syndromes
questionnaire

Additional relevant MeSH terms:
Depression
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases