UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062656 |
|---|---|
| Receipt number | R000071721 |
| Scientific Title | Sleep-related breathing disorder and Nocturia Health Screening Survey |
| Date of disclosure of the study information | 2026/08/22 |
| Last modified on | 2026/08/22 11:53:47 |
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Basic information
Public title
Sleep-related breathing disorder and Nocturia Health Screening Survey
Acronym
SAN-Screen Survey, SSS
Scientific Title
Sleep-related breathing disorder and Nocturia Health Screening Survey
Scientific Title:Acronym
SAN-Screen Survey, SSS
Region
| Japan |
Condition
Condition
Sleep-related breathing disorders (including sleep apnea syndrome), nocturia, and overactive bladder
Classification by specialty
| Pneumology | Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prevalence of sleep-related breathing disorders including obstructive sleep apnea syndrome, nocturia, and overactive bladder using self-administered questionnaires and health screening data in health screening attendees, and to statistically clarify the severity, background factors, and interrelationships of each disease.
Basic objectives2
Others
Basic objectives -Others
Elucidation of the prevalence of and associated factors for sleep-disordered breathing (including sleep apnea syndrome), nocturia, and overactive bladder among local residents (health checkup participants) (epidemiological study)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of sleep-related breathing disorders (including sleep apnea syndrome), nocturia, and overactive bladder.
Key secondary outcomes
Background factors and interrelationships among sleep-related breathing disorders (including obstructive sleep apnea), nocturia, and overactive bladder, as well as quality of life (QoL) scores.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Local residents undergoing health checkups at the health management centers of the respective facilities
2. Aged 18 years or older at the time of obtaining consent
3. No restriction on gender
4. Individuals who have received an appropriate written explanation regarding the conduct of this study and have provided voluntary consent
Key exclusion criteria
1. Individuals who have difficulty making their own decisions regarding study participation or expressing their intent.
2. Individuals with cognitive impairment or mental illness that makes answering the questionnaire extremely difficult.
3. individuals with significant omissions in the questionnaire responses or key health checkup data.
4. Any other individuals deemed unsuitable as study participants by the principal investigator.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Motofumi |
| Middle name | |
| Last name | Suzuki |
Organization
Japan Community Health Care Organization Mishima General Hospital
Division name
Department of Urology
Zip code
411-0801
Address
2276 Fujikubo, Yata, Mishima, Shizuoka, Japan
TEL
+81-55-975-3031
uromotofumi@gmail.com
Public contact
Name of contact person
| 1st name | Motofumi |
| Middle name | |
| Last name | Suzuki |
Organization
Japan Community Health Care Organization Mishima General Hospital
Division name
Department of Urology
Zip code
411-0801
Address
2276 Fujikubo, Yata, Mishima, Shizuoka, Japan
TEL
+81-55-975-3031
Homepage URL
https://mishima.jcho.go.jp/wp-content/uploads/2026/08/R08-06.pdf
suzuki-motofumi@mishima.jcho.go.jp
Sponsor or person
Institute
Japan Community Health Care Organization
Institute
Department
Personal name
Motofumi Suzuki
Funding Source
Organization
Japan Community Health Care Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Community Health Care Organization Mishima General Hospital
Address
2276 Fujikubo, Yata, Mishima, Shizuoka, Japan
Tel
+81-55-975-3031
ishii-takashige@mishima.jcho.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
独立行政法人地域医療機能推進機構三島総合病院（静岡県）
独立行政法人地域医療機能推進機構湯河原病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
https://mishima.jcho.go.jp/wp-content/uploads/2026/08/R08-06.pdf
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2027 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Study Design] Multicenter cross-sectional observational study (Epidemiological study)
[Directionality] Cross-sectional
[Sampling Method] Consecutive health screening attendees who meet the inclusion criteria and provide written informed consent at the health evaluation center of each participating institution will be enrolled (Target sample size: approx. 10,000 cases).
[Factors and Outcomes] Using self-administered questionnaires (JESS, STOP-BANG, OABSS, QoL score) and health screening data (age, sex, BMI, blood pressure, medical history, medication history, etc.), the prevalence of sleep-related breathing disorders including obstructive sleep apnea syndrome, nocturia, and overactive bladder will be evaluated. Furthermore, the severity, background factors, and interrelationships of each disease will be statistically clarified using multivariate analyses.
Management information
Registered date
| 2026 | Year | 08 | Month | 22 | Day |
Last modified on
| 2026 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071721
