UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029267
Receipt number 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 2019/10/21 16:55:31

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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 or person

Institute

Fukuoka Sleep Clinic

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2017 Year 07 Month 01 Day

Date of IRB

2017 Year 01 Month 23 Day

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

2019 Year 10 Month 21 Day



Link to view the page

Value
https://center6.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