UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058228 |
|---|---|
| Receipt number | R000066569 |
| Scientific Title | Establishment of an Obstructive Sleep Apnea Screening Test Based on Lateral Cervical Soft Tissue Radiographs |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/09/16 18:11:16 |
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Basic information
Public title
Establishment of an Obstructive Sleep Apnea Screening Test Based on Lateral Cervical Soft Tissue Radiographs
Acronym
Establishment of an OSA screening test based on lateral cervical radiographs
Scientific Title
Establishment of an Obstructive Sleep Apnea Screening Test Based on Lateral Cervical Soft Tissue Radiographs
Scientific Title:Acronym
Establishment of an OSA screening test based on lateral cervical radiographs
Region
| Japan |
Condition
Condition
obstructive sleep apnea
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish a new, simple, and less invasive screening test to suspect obstructive sleep apnea before PSG (Polysomnography) testing or simple apnomonitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To find indicators that can screen for OSA patients with high AHI based on lateral cervical soft tissue radiographs from four timings of exhalation and inspiration in supine and seated positions, height, weight, gender, and age before PSG testing and apnomonitoring brief examination.
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Disease name: Obstructive sleep apnea
(2)Period covered: Patients with AHI of 30 or more are those presenting as of April 1, 2022; patients with AHI of 30 or less are those presenting from April 2020 to March 2025.
Key exclusion criteria
(1) Those with missing data
Target sample size
386
Research contact person
Name of lead principal investigator
| 1st name | ogawa |
| Middle name | |
| Last name | hiromasa |
Organization
Tohoku University
Division name
Occupational Medicine
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7874
ogawa-hiro@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | kawaguchi |
| Middle name | |
| Last name | yoji |
Organization
Tohoku University
Division name
Occupational Medicine
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7874
Homepage URL
kawaguchi.yoji.s3@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rthics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
Tel
022-728-4105
ec-med@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
| 2025 | Year | 08 | Month | 01 | 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
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
| 2025 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
case-sensitive study
Management information
Registered date
| 2025 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066569
