UMIN-CTR Clinical Trial

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
Email	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
Email	tomoaki-s@med.toho-u.ac.jp

Sponsor
Institute	Toho University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043579