Night in Japan Home Sleep Monitoring Study

Depression Clinical Trial

— NinJaSleep  

Official title:

Epidemiological Study on Insomnia and Depression Using Home Sleep Monitors in a Japanese Rural City Population

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03276585
• Other study ID #: 29-111
• Secondary ID: UMIN000028675
• Status: Enrolling by invitation
• First received: September 3, 2017
• Last updated: April 19, 2018
• Start date: September 6, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2018
• Source: Shiga University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Depression is a major global public health problem and is projected to carry an even greater burden of disease worldwide in the coming decades. Both insomnia and excessive daytime sleepiness (EDS) are sleep disturbance that commonly occur as a principal component of depression. However, studies analyzing objective measurements of EDS or insomnia were very limited. Multiple sleep latency test (MSLT, four nap studies under polytrophic recordings in sleep labs) in psychiatric diseases demonstrated highly heterogeneous results. This may come from most studies had small sample size, which is frequently associated with both depressive symptoms and sleepiness.

Full polysomnography (full-PSG) provides comprehensive information about sleep duration and architecture, but it is too expensive and too cumbersome for large-scale or repeated-measures evaluations (¥96,380/case by Diagnosis Procedure Combination/Per-Diem Payment System in Japan). Using in-laboratory full-PSG as the gold standard has limitations in validity, partly because participants tend to sleep more poorly in the laboratory than at home. Thus, full-PSG may be unsuitable for screening large populations or for repeated evaluations. Actigraphy is a simple method for monitoring locomotor activity and can be used to estimate sleep/wake time but cannot access sleep architecture and sleep staging. Recent advances in electronic technologies and sensor interfaces have enabled small sleep portable monitors. The investigators compared a newly developed single-channel EEG monitoring system (SleepWell Co. Ltd., Osaka, Japan) with simultaneously recorded polysomnography. Single-channel EEG showed reasonable agreement with full-PSG (percent agreement and kappa coefficient of sleep stages were 86.9% ± 4.42 and 0.75 ± 0.081, respectively). This single channel EEG may be suitable to monitor daily sleep more easily in epidemiological settings.

Objective sleep monitoring is important. In measuring excessive daytime sleepiness, for example, subjective evaluation (Epworth sleepiness scale) failed to show much correlation with objective measurements with polygraph recordings. Individuals at high risk for depression have been found to have negative biases in processing information. They may answer subjective insomnia measurements more severely. Previous studies on depression and insomnia came mainly from subjective measures, which may be influenced by such negative evaluation bias. Objective sleep EEG measurements may be useful in overcoming such biases.

Sleep epidemiological study is limited in Japan. For example, sound estimates of prevalence of sleep apnea syndrome in Japan were lacking: previous Japanese studies have been limited by use of nonprobability samples, low response rates, small samples, and other methodologic problems. The investigators have performed sleep epidemiological study in a male working population in Japan. In the study, sleep apnea syndrome (apnea-hypopnea index (AHI) or respiratory event index (REI) ≥15) in males was estimated as 22.3%, which was similar to those in other studies including Sleep Heart Health Study. However, its target population included only Japanese "males". Studies in Japanese females are still missing.

In Japan, employers have to perform annual medical check-ups to their employees including detailed blood biochemical examination. Adding sleep survey to such annual examination, the investigators can analyze detailed physical effects of sleep with minimal costs. Even after the survey, with these annual examinations, the investigators can analyze incidences of lifestyle-related diseases (hypertension, diabetes, dyslipidemia, etc.) in the future.

Recent studies suggest that Rapid eye movement (REM) sleep is important in emotional memory consolidation. REM sleep may be the key between emotional distress and mental disorders: such as insomnia, depression, and posttraumatic stress disorder. To elucidate these interactions, it is essential to perform epidemiological study with sleep EEG monitoring. Without EEG, the investigators cannot analyze REM sleep at all.

In this study, the investigators plan to analyze around 1,000 participants and analyze sleep EEG at home. This will make a big difference, because participants usually sleep poorer in sleep laboratory than at home.

The investigators have performed questionnaire surveys on insomnia and depression among local government employees in Koka, Shiga prefecture, Japan since 2014. The investigators have good relationship with Koka city government and participation rate to the surveys were as high as 93%, whose mean age was 42.0±10.3 years (range: 18-61 years) .

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.

The database, constructed during this project, will serve as fundamentals in the future studies in analyzing mental stress, insomnia, depression, lifestyle-related diseases and social costs in the general population. In the follow-up studies in the future, the investigators will also analyze cardio-vascular attach events, cerebrovascular attach events, sick leaves, incidents of depression and/or insomnia in the subgroups.

The investigators plan to get funding from Japanese ministry of education science and culture to perform home sleep apnea testing. Because sleep apnea is a very prevalent sleep disorder (over 20% of males have moderate-to-severe sleep apnea with 15 times per hour or more of apnea/hypopnea events). Participants usually wake up for a short period (arousal) after each apnea/hypopnea event, which cause sleep fragmentation in PSG/EEG. Sleep apnea syndrome is a risk factor for depressive symptoms and sleepiness.

When some part of this population (for example, 50% of participants with depression and similar number of those without) undergo clinical diagnostic interviews by psychiatrists, the investigators can use this data to develop diagnostic tool for depression in the future.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: August 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Subjects who need legally acceptable representative to consent.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Sleep Initiation and Maintenance Disorders

Locations

Country	Name	City	State
Japan	Shiga University of Medical Science	Otsu	Shiga

Sponsors (3)

Lead Sponsor	Collaborator
Shiga University	Koka city, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Single-channel Electroencephalogram (EEG)	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.	1 week
Other	Respiratory Event Index (REI)	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.	1 week
Other	Chalder fatigue scale	Chalder fatigue scale is a self-rating score, which is now widely used to measure the severity of 'tiredness'.	2 weeks
Other	General Anxiety Disorder-7 (GAD-7)	GAD-7 is a 7-item self-administrated questionnaire, which assess generalized anxiety disorder.	2 weeks
Other	FIRST (Ford Insomnia Response to Stress Test)	FIRST is a 9-item self-rating score measuring the likelihood of the occurrence of sleep disturbances in response to commonly experienced stressful situations.	2 weeks
Other	8-Item Short-Form Health Survey (SF-8)	The SF-8 is an 8-item self-administrated questionnaire, which assess health-related quality of life.	1 month
Other	WHO Health and Work Performance Questionnaire (WHO-HPQ)	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).	1 month
Other	The Brief Job Stress Questionnaire	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.	1 month
Other	Athens Insomnia Scale (AIS)	AIS is an 8-item self-administrated questionnaire, which assess Insomnia.	1 month
Other	the Circadian Energy Scale (CIRENS)	CIRENS is a very short and simple chronotype measurement tool based on energy.	2 weeks
Other	Four-Variable Screening Tool	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).	2 weeks
Primary	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	Patient Health Questionnaire (PHQ-9)	PHQ-9 is a 9-item self-administrated questionnaire, which assess Major depressive disorder.	2 weeks
Secondary	Epworth Sleepiness Scale (ESS)	ESS is a 8-item self-administrated questionnaire, which assess the sleepiness.	2 weeks