UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030737 |
|---|---|
| Receipt number | R000035100 |
| Scientific Title | Impacts of sleep-related dynamic upper airway collapse in Japanese adults with obstructive sleep apnea. a retrospective study |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2023/07/18 06:03:04 |
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Basic information
Public title
Impacts of sleep-related dynamic upper airway collapse in Japanese adults with obstructive sleep apnea. a retrospective study
Acronym
Impacts of sleep-related dynamic upper airway collapse in Japanese with OSA
Scientific Title
Impacts of sleep-related dynamic upper airway collapse in Japanese adults with obstructive sleep apnea. a retrospective study
Scientific Title:Acronym
Impacts of sleep-related dynamic upper airway collapse in Japanese with OSA
Region
| Japan |
Condition
Condition
obstructive sleep apnea
Classification by specialty
| Pneumology | Oto-rhino-laryngology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of prevalence of patient with sleep-related dynamic upper airway collapse in OSA
Basic objectives2
Others
Basic objectives -Others
Evaluation of severity of sleep-related dynamic upper airway collapse
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of prevalence of patient with sleep-related dynamic upper airway collapse in OSA
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
polysomnography was performed
Key exclusion criteria
1 any active malignancies
2 post operation of airway
3 tracheobronchomalacia
4 excessive dynamic airway collapse
5 relapsing polychondritis
6 vocal cord dysfunction
7 Mounier-Kuhn syndrome
8 Congenital deficiency of muscularis mucosa
9 Ehlers-Danlos syndrome
10 any diseases of thyroid organ
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | |
| Last name | Kawayama |
Organization
Kurume University School of Medicine
Division name
Department of medicine
Zip code
830-0011
Address
67 Asahimachi, Kurume
TEL
0942-31-7560
kawayama_tomotaka@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomotaka |
| Middle name | |
| Last name | Kawayama |
Organization
Kurume University School of Medicine
Division name
Department of medicine
Zip code
830-0011
Address
67 Asahimachi, Kurume
TEL
0942-31-7560
Homepage URL
kawayama_tomotaka@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
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
Kurume University
Address
67 Asahimachi, Kurume
Tel
0942-35-3311
sangakuml@kurume-u.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
| 2018 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000035100
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Cause of pandemic corona viral infection
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
a retrospective study
Management information
Registered date
| 2018 | Year | 01 | Month | 09 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035100
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/07/18 | 2_OSA&MRI_研究計画書_01152020.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/07/18 | 7_ケースカード_OSA&MRI_12252019.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/07/18 | 10-2_OSA&MRI_連結表_UMIN用_07182023.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/35100
