Depression Clinical Trial
Official title:
Epidemiological Study on Insomnia and Depression Using Home Sleep Monitors in a Japanese Rural City Population
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.
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.
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