Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000373774
Ethics application status
Approved
Date submitted
28/03/2013
Date registered
8/04/2013
Date last updated
9/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The clinical efficiency of positive airway pressure (PAP) treatment in patients with moderate-severe obstructive sleep apnea syndrome (OSAS)
Scientific title
A study evaluating the clinical efficiency and compliance of positive airway pressure (PAP) treatment on patients with moderate-severe obstructive sleep apnea syndroma (OSAS)
Secondary ID [1] 282207 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 288726 0
Condition category
Condition code
Respiratory 289081 289081 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Arm 1: device
(In moderate-severe OSAS patients main treatment is positive airway pressure (PAP) device. We have investigated the efficiancy of this device.)
In obstructive sleep apnea patients the saturation of oxygen level are under normal level. In some patients we measure that about 30-40% PAP device positive pressure. Low oxygen levels are associated with chronic disease as myocardial infarction. When apnea appears in patients and saturation of the oxygen level decreases PAP device improve saturation of oxygen by positive pressure. Patients should use the device every night. Patients who are using the device for more than 6 months (between 6-12months) will be observed.
Intervention code [1] 286821 0
Not applicable
Comparator / control treatment
In this study we just observed the patients using positive airway pressure device-This is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289216 0
Positive airway pressure therapy provides significant improvements in sleep and quality of life.
We use questionnaire method to maintain this knowledge.
Timepoint [1] 289216 0
At 6 months after patients have begun using PAP
Secondary outcome [1] 302005 0
When evaluating the efficiancy of positive airway pressure treatment we used Epworth Sleepines Scale (ESS) and 2 other questionnaire which we prepared for Turkish patients. This kind of questionarre could be used in these syudies.
Timepoint [1] 302005 0
At 6 months after patients have begun using PAP

Eligibility
Key inclusion criteria
Obstruvtive Sleep Apnea patients with AHI>5 (apnea hypopnea index)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
AHI<5 (apnea hypopnea index)

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2008
Actual
1/01/2008
Date of last participant enrolment
Anticipated
1/04/2011
Actual
1/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 4959 0
Turkey
State/province [1] 4959 0
ankara

Funding & Sponsors
Funding source category [1] 286970 0
Self funded/Unfunded
Name [1] 286970 0
Country [1] 286970 0
Turkey
Primary sponsor type
Individual
Name
Sabri Koseoglu
Address
Mebusevleri Mahallesi, Iller sokak,12/05 tandogan ANKARA
Country
Turkey
Secondary sponsor category [1] 285760 0
None
Name [1] 285760 0
Address [1] 285760 0
Country [1] 285760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289019 0
Ankara Numune Education and Research Hospital Ethical Committee
Ethics committee address [1] 289019 0
Ethics committee country [1] 289019 0
Turkey
Date submitted for ethics approval [1] 289019 0
01/01/2013
Approval date [1] 289019 0
14/01/2013
Ethics approval number [1] 289019 0
551/2013

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38826 0
Dr Sabri Koseoglu
Address 38826 0
Mebusevleri Mahallesi , Iller Sok, 12/5, 06640, Tandogan/ANKARA
Country 38826 0
Turkey
Phone 38826 0
+905056459911
Fax 38826 0
Email 38826 0
[email protected]
Contact person for public queries
Name 38827 0
Sabri Koseoglu
Address 38827 0
Mebusevleri Mahallesi , Iller Sok, 12/5, 06640, Tandogan/ANKARA
Country 38827 0
Turkey
Phone 38827 0
+905056459911
Fax 38827 0
Email 38827 0
[email protected]
Contact person for scientific queries
Name 38828 0
sabri Koseoglu
Address 38828 0
Mebusevleri Mahallesi , Iller Sok, 12/5, 06640, Tandogan/ANKARA
Country 38828 0
Turkey
Phone 38828 0
+905056459911
Fax 38828 0
Email 38828 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes April 29 2013

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe Clinical Efficiency of Positive Airway Pressure Treatment2013https://doi.org/10.1155/2013/245476
N.B. These documents automatically identified may not have been verified by the study sponsor.