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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029267
Receipt No. R000033452
Scientific Title Effects of Sleep Apnea and Continuous Positive Pressure Breathing on Intraocular Pressure
Date of disclosure of the study information 2017/09/25
Last modified on 2018/09/12

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Basic information
Public title Effects of Sleep Apnea and Continuous Positive Pressure Breathing on Intraocular Pressure
Acronym Sleep Apnea, CPAP and Intraocular Pressure
Scientific Title Effects of Sleep Apnea and Continuous Positive Pressure Breathing on Intraocular Pressure
Scientific Title:Acronym Sleep Apnea, CPAP and Intraocular Pressure
Region
Japan

Condition
Condition Obstructive Sleep Apnea
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the effects of CPAP on intraocular pressure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Differences of the intraocular pressure among the groups with and without CPAP therapy.
Key secondary outcomes 1: Differences of intraocular pressure before and after the CPAP therapy
2: Differences of the following parameters between before and after CPAP theapy.
Parameters of the polysomnography
Hemodynamic parameters
Circumferences of the neck and the lowe leg

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 CPAP treatment during the last half of 7 hours night sleep.
Interventions/Control_2 No CPAP treatment as a control
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients who meet the following criterias
1: ODI3%>= 20
2: 17<= BMI <40
Key exclusion criteria Patients who meet one of the following criterias are excluded.
1:Patients with severe heart failure
2:Patients with severe respiratory failure
3:Patients with dementia
4:Patients with severe sleep disease other than SAS
5:Patients with some significant disease which influence CPAP therapy
6:Patients with significant eye disease other than glaucoma
7:Patients whose docter in charge do not agree to join this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takero Fukutome
Organization Fukuoka Sleep Clinic
Division name Fukuoka Sleep Clinic
Zip code
Address Chambord B 1301, Chyuoku 2-10--2, Fukuoka City
TEL 092-400-2007
Email fukuoka_suimin@aurora.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takero Fukutome
Organization Fukuoka Sleep Clinic
Division name Fukuoka Sleep Clinic
Zip code
Address Chambord B 1301, Chyuoku 2-10--2, Fukuoka City
TEL 092-400-2007
Homepage URL
Email fukuoka_suimin@aurora.ocn.ne.jp

Sponsor
Institute Fukuoka Sleep Clinic
Institute
Department

Funding Source
Organization Fukuoka Sleep Clinic
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
Address
Tel
Email

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
2017 Year 09 Month 25 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
Data was obtained from 28 subjects
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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 25 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 24 Day
Last modified on
2018 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033452

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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