UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051186 |
|---|---|
| Receipt number | R000058379 |
| Scientific Title | Verification of the validity of a predictive model for sleep apnea syndrome based on regular health checkup items |
| Date of disclosure of the study information | 2023/05/29 |
| Last modified on | 2024/05/29 10:05:31 |
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Basic information
Public title
Verification of a method to infer sleep apnea syndrome from health checkup results
Acronym
Verification of a method to infer SAS from HC results
Scientific Title
Verification of the validity of a predictive model for sleep apnea syndrome based on regular health checkup items
Scientific Title:Acronym
Verification of the validity of a predictive model for SAS based on regular HC items
Region
| Japan |
Condition
Condition
sleep apnea syndrome
Classification by specialty
| Pneumology | Oto-rhino-laryngology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the validity of a predictive model for sleep apnea syndrome based on regular health checkup items
Basic objectives2
Others
Basic objectives -Others
Verification
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory Event Index (REI) in All-Night Percutaneous Arterial Oxygen Saturation Measurement Results
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
All-Night Percutaneous Arterial Oxygen Saturation Measurement
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Staffs of Tohoku University Hospital
Key exclusion criteria
People with insufficient data such as missing records, patients with diseases that may affect the values of each item (chronic renal failure, blood diseases), and patients with rare diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University School of Medicine
Division name
Department of Occupational Health
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi JAPAN
TEL
0227177874
ogawa-hiro@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kyoka |
| Middle name | |
| Last name | Kanno |
Organization
Tohoku University School of Medicine
Division name
Department of Occupational Health
Zip code
9808575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi JAPAN
TEL
0227177874
Homepage URL
kanno.kyoka.s4@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
0227178007
med-kenkyo@grp.tohoku.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058379
