UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020195
Receipt number R000023324
Scientific Title Treatment Adherence and Outcomes in Three Modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea
Date of disclosure of the study information 2015/12/15
Last modified on 2015/12/22 10:39:08

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Basic information

Public title

Treatment Adherence and Outcomes in Three Modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea

Acronym

Flexible PAP for OSA

Scientific Title

Treatment Adherence and Outcomes in Three Modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea

Scientific Title:Acronym

Flexible PAP for OSA

Region

Japan


Condition

Condition

Obstructive sleep apnea

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

objective CPAP adherence after 3 months of CPAP treatment(objective adherence are downloaded and reported by the memory card located in the CPAP device.)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

APAP(3 months)

Interventions/Control_2

C-flex(3 months)

Interventions/Control_3

A-flex(3 months)

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

Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
Subjects diagnosed with OSA (apnea hypopnea index >=5/hour) by overnight polysomnography.

Key exclusion criteria

Subjects diagnosed with CSA by overnight polysomnography.
Subjects ever used CPAP for OSA.

Target sample size

93


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Chin

Organization

Kyoto University Graduate School of Medicine

Division name

Departments of Respiratory Care and Sleep Control Medicine

Zip code


Address

54 Shogoin Kawahara-cho, Sakyo-Ku, Kyoto 606-8507, Japan.

TEL

075-751-3852

Email

chink@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuo Chin

Organization

Kyoto University Graduate School of Medicine

Division name

Departments of Respiratory Care and SleepControl Medicine

Zip code


Address

54 Shogoin Kawahara-cho, Sakyo-Ku, Kyoto 606-8507, Japan.

TEL

075-751-3852

Homepage URL


Email

chink@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Health, Labor and Welfare of Japan

Organization

Division

Category of Funding Organization

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

YES

Study ID_1

NCT00873977

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

2009 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 12 Month 14 Day

Last modified on

2015 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023324


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name