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Sleep Initiation and Maintenance DisordersNinJaSleepNCT03276585

Night in Japan Home Sleep Monitoring Study

An observational study of Sleep Initiation and Maintenance Disorders and Depression, run by Shiga University at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
How many people
2,000 participants
Where
1 siteJapan
Study dates
6 Sep 2017to 31 Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Koka city government employees (Koka city, Shiga prefecture, Japan)

Who may be able to join

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

Who cannot join

  • Subjects who need legally acceptable representative to consent.

Trial locations and contacts

1 site in 1 country.

Japan1 site
  • Shiga University of Medical Science

    Ōtsu, Shiga, 520-2192

Other trials in Japan

About this study

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.

Read the 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.

Keywords
home sleep monitor, Sleep Apnea Syndromes, questionnaire
Medical subject headings
Sleep Initiation and Maintenance Disorders, Depression, Sleep Apnea Syndromes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 weeks

Secondary outcomes (2)
  1. Patient Health Questionnaire (PHQ-9)

    PHQ-9 is a 9-item self-administrated questionnaire, which assess Major depressive disorder.

    Measured: 2 weeks

  2. Epworth Sleepiness Scale (ESS)

    ESS is a 8-item self-administrated questionnaire, which assess the sleepiness.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2017
  2. Study start6 Sep 2017
  3. Primary completion31 Mar 2019 (estimated)
  4. Study completion31 Aug 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03276585
Sponsor's protocol ID
29-111
Other IDs
UMIN000028675
Acronym
NinJaSleep
Status last verified
Apr 2018
First submitted
3 Sep 2017
Last updated
20 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We have not decided with whom to collaborate.

Publications

  • Omichi C, Kaminishi Y, Kadotani H, Sumi Y, Ubara A, Nishikawa K, Matsuda A, Ozeki Y. Limited social support is associated with depression, anxiety, and insomnia in a Japanese working population. Front Public Health. 2022 Nov 21;10:981592. doi: 10.3389/fpubh.2022.981592. eCollection 2022.

    PubMed 36483246

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Initiation and Maintenance Disorders and Depression, run by Shiga University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia Severity Index (ISI) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03276585, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.

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