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.
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
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Depression
- 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.
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.
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)
Patient Health Questionnaire (PHQ-9)
PHQ-9 is a 9-item self-administrated questionnaire, which assess Major depressive disorder.
Measured: 2 weeks
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.
- First posted8 Sep 2017
- Study start6 Sep 2017
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shiga University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Koka city
- Responsible party
- Sponsor
- Investigators
- Hiroshi Kadotani, MD,PhD, Principal investigator, Department of Sleep and Behavioral Sciences, Shiga University of Medical Science
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on Insomnia and Depression Using Home Sleep Monitors in a Japanese Rural City Population
- ClinicalTrials.gov ID
- NCT03276585
- Acronym / sponsor ID
- NinJaSleep / 29-111
- Keywords
- home sleep monitor, Sleep Apnea Syndromes, questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shiga UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Koka city
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Koka city government employees (Koka city, Shiga prefecture, Japan)
Key inclusion criteria (1 listed)
- Koka city government employees (Koka city, Shiga prefecture, Japan)
Key exclusion criteria (1 listed)
- Subjects who need legally acceptable representative to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 2 weeks
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 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: 2 weeks
Epworth Sleepiness Scale (ESS)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Derived from this study: PubMed 36483246Omichi 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.
- Individual participant dataSharing planned: Undecided. We have not decided with whom to collaborate.
Related trials for Sleep Initiation and Maintenance Disorders
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroshi Kadotani, MD,PhD principal investigator
Department of Sleep and Behavioral Sciences, Shiga University of Medical Science
1 site in 1 country: see every site and its status.
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.