<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03276585</url>
  </required_header>
  <id_info>
    <org_study_id>29-111</org_study_id>
    <secondary_id>UMIN000028675</secondary_id>
    <nct_id>NCT03276585</nct_id>
  </id_info>
  <brief_title>Night in Japan Home Sleep Monitoring Study</brief_title>
  <acronym>NinJaSleep</acronym>
  <official_title>Epidemiological Study on Insomnia and Depression Using Home Sleep Monitors in a Japanese Rural City Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shiga University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Koka city</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shiga University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesized that depression is associated with home sleep EEG, subjective&#xD;
      sleepiness and insomnia symptoms. To test this, the investigators plan to perform sleep&#xD;
      examination with single channel EEG, in combination with questionnaire survey for insomnia,&#xD;
      sleepiness, depression and job stress to Koka city government employees.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is a major global public health problem and is projected to carry an even greater&#xD;
      burden of disease worldwide in the coming decades. Both insomnia and excessive daytime&#xD;
      sleepiness (EDS) are sleep disturbance that commonly occur as a principal component of&#xD;
      depression. However, studies analyzing objective measurements of EDS or insomnia were very&#xD;
      limited. Multiple sleep latency test (MSLT, four nap studies under polytrophic recordings in&#xD;
      sleep labs) in psychiatric diseases demonstrated highly heterogeneous results. This may come&#xD;
      from most studies had small sample size, which is frequently associated with both depressive&#xD;
      symptoms and sleepiness.&#xD;
&#xD;
      Full polysomnography (full-PSG) provides comprehensive information about sleep duration and&#xD;
      architecture, but it is too expensive and too cumbersome for large-scale or repeated-measures&#xD;
      evaluations (¥96,380/case by Diagnosis Procedure Combination/Per-Diem Payment System in&#xD;
      Japan). Using in-laboratory full-PSG as the gold standard has limitations in validity, partly&#xD;
      because participants tend to sleep more poorly in the laboratory than at home. Thus, full-PSG&#xD;
      may be unsuitable for screening large populations or for repeated evaluations. Actigraphy is&#xD;
      a simple method for monitoring locomotor activity and can be used to estimate sleep/wake time&#xD;
      but cannot access sleep architecture and sleep staging. Recent advances in electronic&#xD;
      technologies and sensor interfaces have enabled small sleep portable monitors. The&#xD;
      investigators compared a newly developed single-channel EEG monitoring system (SleepWell Co.&#xD;
      Ltd., Osaka, Japan) with simultaneously recorded polysomnography. Single-channel EEG showed&#xD;
      reasonable agreement with full-PSG (percent agreement and kappa coefficient of sleep stages&#xD;
      were 86.9% ± 4.42 and 0.75 ± 0.081, respectively). This single channel EEG may be suitable to&#xD;
      monitor daily sleep more easily in epidemiological settings.&#xD;
&#xD;
      Objective sleep monitoring is important. In measuring excessive daytime sleepiness, for&#xD;
      example, subjective evaluation (Epworth sleepiness scale) failed to show much correlation&#xD;
      with objective measurements with polygraph recordings. Individuals at high risk for&#xD;
      depression have been found to have negative biases in processing information. They may answer&#xD;
      subjective insomnia measurements more severely. Previous studies on depression and insomnia&#xD;
      came mainly from subjective measures, which may be influenced by such negative evaluation&#xD;
      bias. Objective sleep EEG measurements may be useful in overcoming such biases.&#xD;
&#xD;
      Sleep epidemiological study is limited in Japan. For example, sound estimates of prevalence&#xD;
      of sleep apnea syndrome in Japan were lacking: previous Japanese studies have been limited by&#xD;
      use of nonprobability samples, low response rates, small samples, and other methodologic&#xD;
      problems. The investigators have performed sleep epidemiological study in a male working&#xD;
      population in Japan. In the study, sleep apnea syndrome (apnea-hypopnea index (AHI) or&#xD;
      respiratory event index (REI) ≥15) in males was estimated as 22.3%, which was similar to&#xD;
      those in other studies including Sleep Heart Health Study. However, its target population&#xD;
      included only Japanese &quot;males&quot;. Studies in Japanese females are still missing.&#xD;
&#xD;
      In Japan, employers have to perform annual medical check-ups to their employees including&#xD;
      detailed blood biochemical examination. Adding sleep survey to such annual examination, the&#xD;
      investigators can analyze detailed physical effects of sleep with minimal costs. Even after&#xD;
      the survey, with these annual examinations, the investigators can analyze incidences of&#xD;
      lifestyle-related diseases (hypertension, diabetes, dyslipidemia, etc.) in the future.&#xD;
&#xD;
      Recent studies suggest that Rapid eye movement (REM) sleep is important in emotional memory&#xD;
      consolidation. REM sleep may be the key between emotional distress and mental disorders: such&#xD;
      as insomnia, depression, and posttraumatic stress disorder. To elucidate these interactions,&#xD;
      it is essential to perform epidemiological study with sleep EEG monitoring. Without EEG, the&#xD;
      investigators cannot analyze REM sleep at all.&#xD;
&#xD;
      In this study, the investigators plan to analyze around 1,000 participants and analyze sleep&#xD;
      EEG at home. This will make a big difference, because participants usually sleep poorer in&#xD;
      sleep laboratory than at home.&#xD;
&#xD;
      The investigators have performed questionnaire surveys on insomnia and depression among local&#xD;
      government employees in Koka, Shiga prefecture, Japan since 2014. The investigators have good&#xD;
      relationship with Koka city government and participation rate to the surveys were as high as&#xD;
      93%, whose mean age was 42.0±10.3 years (range: 18-61 years) .&#xD;
&#xD;
      The investigators hypothesized that depression is associated with home sleep EEG, subjective&#xD;
      sleepiness and insomnia symptoms. To test this, the investigators plan to perform sleep&#xD;
      examination with single channel EEG, in combination with questionnaire survey for insomnia,&#xD;
      sleepiness, depression and job stress to Koka city government employees.&#xD;
&#xD;
      The database, constructed during this project, will serve as fundamentals in the future&#xD;
      studies in analyzing mental stress, insomnia, depression, lifestyle-related diseases and&#xD;
      social costs in the general population. In the follow-up studies in the future, the&#xD;
      investigators will also analyze cardio-vascular attach events, cerebrovascular attach events,&#xD;
      sick leaves, incidents of depression and/or insomnia in the subgroups.&#xD;
&#xD;
      The investigators plan to get funding from Japanese ministry of education science and culture&#xD;
      to perform home sleep apnea testing. Because sleep apnea is a very prevalent sleep disorder&#xD;
      (over 20% of males have moderate-to-severe sleep apnea with 15 times per hour or more of&#xD;
      apnea/hypopnea events). Participants usually wake up for a short period (arousal) after each&#xD;
      apnea/hypopnea event, which cause sleep fragmentation in PSG/EEG. Sleep apnea syndrome is a&#xD;
      risk factor for depressive symptoms and sleepiness.&#xD;
&#xD;
      When some part of this population (for example, 50% of participants with depression and&#xD;
      similar number of those without) undergo clinical diagnostic interviews by psychiatrists, the&#xD;
      investigators can use this data to develop diagnostic tool for depression in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>2 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>2 weeks</time_frame>
    <description>PHQ-9 is a 9-item self-administrated questionnaire, which assess Major depressive disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>2 weeks</time_frame>
    <description>ESS is a 8-item self-administrated questionnaire, which assess the sleepiness.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Single-channel Electroencephalogram (EEG)</measure>
    <time_frame>1 week</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Respiratory Event Index (REI)</measure>
    <time_frame>1 week</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Chalder fatigue scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Chalder fatigue scale is a self-rating score, which is now widely used to measure the severity of 'tiredness'.</description>
  </other_outcome>
  <other_outcome>
    <measure>General Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>2 weeks</time_frame>
    <description>GAD-7 is a 7-item self-administrated questionnaire, which assess generalized anxiety disorder.</description>
  </other_outcome>
  <other_outcome>
    <measure>FIRST (Ford Insomnia Response to Stress Test)</measure>
    <time_frame>2 weeks</time_frame>
    <description>FIRST is a 9-item self-rating score measuring the likelihood of the occurrence of sleep disturbances in response to commonly experienced stressful situations.</description>
  </other_outcome>
  <other_outcome>
    <measure>8-Item Short-Form Health Survey (SF-8)</measure>
    <time_frame>1 month</time_frame>
    <description>The SF-8 is an 8-item self-administrated questionnaire, which assess health-related quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>WHO Health and Work Performance Questionnaire (WHO-HPQ)</measure>
    <time_frame>1 month</time_frame>
    <description>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).</description>
  </other_outcome>
  <other_outcome>
    <measure>The Brief Job Stress Questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>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 &quot;high-stress&quot; workers.</description>
  </other_outcome>
  <other_outcome>
    <measure>Athens Insomnia Scale (AIS)</measure>
    <time_frame>1 month</time_frame>
    <description>AIS is an 8-item self-administrated questionnaire, which assess Insomnia.</description>
  </other_outcome>
  <other_outcome>
    <measure>the Circadian Energy Scale (CIRENS)</measure>
    <time_frame>2 weeks</time_frame>
    <description>CIRENS is a very short and simple chronotype measurement tool based on energy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Four-Variable Screening Tool</measure>
    <time_frame>2 weeks</time_frame>
    <description>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).</description>
  </other_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Sleep Initiation and Maintenance Disorders</condition>
  <condition>Depression</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Koka city government employees (Koka city, Shiga prefecture, Japan)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Koka city government employees (Koka city, Shiga prefecture, Japan)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who need legally acceptable representative to consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hiroshi Kadotani, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Sleep and Behavioral Sciences, Shiga University of Medical Science</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shiga University of Medical Science</name>
      <address>
        <city>Otsu</city>
        <state>Shiga</state>
        <zip>520-2192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>April 19, 2018</last_update_submitted>
  <last_update_submitted_qc>April 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>home sleep monitor</keyword>
  <keyword>Sleep Apnea Syndromes</keyword>
  <keyword>questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We have not decided with whom to collaborate.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03276585
org study id: 29-111
secondary id: UMIN000028675
nct id: NCT03276585
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Insomnia Severity Index (ISI)
time frame: 2 weeks
description: 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.
measure: Patient Health Questionnaire (PHQ-9)
time frame: 2 weeks
description: PHQ-9 is a 9-item self-administrated questionnaire, which assess Major depressive disorder.
measure: Epworth Sleepiness Scale (ESS)
time frame: 2 weeks
description: ESS is a 8-item self-administrated questionnaire, which assess the sleepiness.
measure: Single-channel Electroencephalogram (EEG)
time frame: 1 week
description: 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.
measure: Respiratory Event Index (REI)
time frame: 1 week
description: 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.
measure: Chalder fatigue scale
time frame: 2 weeks
description: Chalder fatigue scale is a self-rating score, which is now widely used to measure the severity of 'tiredness'.
measure: General Anxiety Disorder-7 (GAD-7)
time frame: 2 weeks
description: GAD-7 is a 7-item self-administrated questionnaire, which assess generalized anxiety disorder.
measure: FIRST (Ford Insomnia Response to Stress Test)
time frame: 2 weeks
description: FIRST is a 9-item self-rating score measuring the likelihood of the occurrence of sleep disturbances in response to commonly experienced stressful situations.
measure: 8-Item Short-Form Health Survey (SF-8)
time frame: 1 month
description: The SF-8 is an 8-item self-administrated questionnaire, which assess health-related quality of life.
measure: WHO Health and Work Performance Questionnaire (WHO-HPQ)
time frame: 1 month
description: 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).
measure: The Brief Job Stress Questionnaire
time frame: 1 month
description: 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.
measure: Athens Insomnia Scale (AIS)
time frame: 1 month
description: AIS is an 8-item self-administrated questionnaire, which assess Insomnia.
measure: the Circadian Energy Scale (CIRENS)
time frame: 2 weeks
description: CIRENS is a very short and simple chronotype measurement tool based on energy.
measure: Four-Variable Screening Tool
time frame: 2 weeks
description: 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).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hiroshi Kadotani, MD,PhD
role: Principal Investigator
affiliation: Department of Sleep and Behavioral Sciences, Shiga University of Medical Science
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Depression
sharing ipd: Undecided
ipd description: We have not decided with whom to collaborate.