UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038230 |
|---|---|
| Receipt number | R000043579 |
| Scientific Title | Evaluation ocular blood flow using laser speckle flowgraphy Evaluation of ocular blood flow in patients with sleep apnea syndrome |
| Date of disclosure of the study information | 2019/10/08 |
| Last modified on | 2019/10/08 11:34:22 |
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Basic information
Public title
Evaluation of effectiveness of CPAP for patients with sleep apnea syndrome.
Evaluation of ocular blood flow in patients with sleep apnea syndrome
Acronym
SAS and ocular blood flow
Scientific Title
Evaluation ocular blood flow using laser speckle flowgraphy
Evaluation of ocular blood flow in patients with sleep apnea syndrome
Scientific Title:Acronym
SAS and ocular blood flow
Region
| Japan |
Condition
Condition
Sleep apnea syndrome
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate ocular blood flow in patients with sleep apnea syndrome laser speckle flowgraphy
Basic objectives2
Others
Basic objectives -Others
Optic nerve head circulation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation the mean blur rate on the optic nerve head
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who received polysomnography
Key exclusion criteria
central sleep apnea
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mao |
| Middle name | |
| Last name | Takahashi |
Organization
Cardiovascular center, Toho University Sakura Medical Center
Division name
Cardiovascular center
Zip code
285-8541
Address
Shimoshizu, Sakura 564-1 Chiba
TEL
043-462-8811
takahashi-04@sakura.med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Shiba |
Organization
Toho University Omori Medical Center
Division name
Ophthalmology
Zip code
143-8541
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
Homepage URL
tomoaki-s@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho 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
Toho University Sakura Medical Center
Address
Shimoshizu, Sakura 564-1 Chiba
Tel
043-462-8811
takahashi-04@sakura.med.toho-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
| 2019 | Year | 10 | Month | 08 | 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
236
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
Completed
Date of protocol fixation
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 10 | Month | 08 | Day |
Last modified on
| 2019 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043579
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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