Clinical trial NCT03276585: Night in Japan Home Sleep Monitoring Study
Official title: Epidemiological Study on Insomnia and Depression Using Home Sleep Monitors in a Japanese Rural City Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Initiation and Maintenance Disorders
Depression
Keywords: home sleep monitor
Sleep Apnea Syndromes
questionnaire
Lead sponsor: Shiga University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Koka city
First posted: 2017-09-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Koka city government employees (Koka city, Shiga prefecture, Japan)

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Subjects who need legally acceptable representative to consent.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 2 weeks
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 2 weeks
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 2 weeks
Other outcomes:
measure: Single-channel Electroencephalogram (EEG)
timeFrame: 1 week
measure: Respiratory Event Index (REI)
timeFrame: 1 week
measure: Chalder fatigue scale
timeFrame: 2 weeks
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: 2 weeks
measure: FIRST (Ford Insomnia Response to Stress Test)
timeFrame: 2 weeks
measure: 8-Item Short-Form Health Survey (SF-8)
timeFrame: 1 month
measure: WHO Health and Work Performance Questionnaire (WHO-HPQ)
timeFrame: 1 month
measure: The Brief Job Stress Questionnaire
timeFrame: 1 month
measure: Athens Insomnia Scale (AIS)
timeFrame: 1 month
measure: the Circadian Energy Scale (CIRENS)
timeFrame: 2 weeks
measure: Four-Variable Screening Tool
timeFrame: 2 weeks
Locations:
city: Otsu
country: Japan
facility: Shiga University of Medical Science
state: Shiga
Study officials:
affiliation: Department of Sleep and Behavioral Sciences, Shiga University of Medical Science
name: Hiroshi Kadotani, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: