Night in Japan Home Sleep Monitoring Study (NinJaSleep)
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|ClinicalTrials.gov Identifier: NCT03276585|
Recruitment Status : Enrolling by invitation
First Posted : September 8, 2017
Last Update Posted : April 20, 2018
|Condition or disease|
|Sleep Initiation and Maintenance Disorders Depression|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Epidemiological Study on Insomnia and Depression Using Home Sleep Monitors in a Japanese Rural City Population|
|Actual Study Start Date :||September 6, 2017|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
- 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.
- Patient Health Questionnaire (PHQ-9) [ Time Frame: 2 weeks ]PHQ-9 is a 9-item self-administrated questionnaire, which assess Major depressive disorder.
- Epworth Sleepiness Scale (ESS) [ Time Frame: 2 weeks ]ESS is a 8-item self-administrated questionnaire, which assess the sleepiness.
- 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.
- Respiratory Event Index (REI) [ Time Frame: 1 week ]REI (numbers of apneas and hypopneas divided by recorded hours with home sleep testings), is used for diagnosis and severity definition of sleep apnea syndrome.
- 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'.
- General Anxiety Disorder-7 (GAD-7) [ Time Frame: 2 weeks ]GAD-7 is a 7-item self-administrated questionnaire, which assess generalized anxiety disorder.
- 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.
- 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.
- 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).
- 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.
- Athens Insomnia Scale (AIS) [ Time Frame: 1 month ]AIS is an 8-item self-administrated questionnaire, which assess Insomnia.
- the Circadian Energy Scale (CIRENS) [ Time Frame: 2 weeks ]CIRENS is a very short and simple chronotype measurement tool based on energy.
- Four-Variable Screening Tool [ Time Frame: 2 weeks ]With knowledge of only 4 easily ascertainable variables, moderate-to-severe sleep apnea syndrome can be easily detected in clinical and public health settings (SLEEP 2009;32(7):939-948).
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
|Shiga University of Medical Science|
|Otsu, Shiga, Japan, 520-2192|
|Principal Investigator:||Hiroshi Kadotani, MD,PhD||Department of Sleep and Behavioral Sciences, Shiga University of Medical Science|