Patient Education and PAP Compliance in OSA | NCT02756299

Studies
Patient Education and PAP Compliance in OSA

NCT02756299

Sponsor

Marmara University

Status

Completed

Last Update Posted

May 2, 2016Estimated

Enrollment

115Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Educational Support
Standard Support

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Apr 25, 2016

First Submission Date that Met QC Criteria

Apr 26, 2016

First Posted Date

Apr 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2016

Last Update Posted Date

May 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Obstructive sleep apnea (OSA) is a common disorder with serious complications. Positive airway pressure (PAP) is the first line treatment of OSA, which eliminates obstructive events, reduces daytime sleepiness, and improves quality of life, especially in those with excessive daytime sleepiness. However, despite the benefits of the PAP treatment, overall acceptance and adherence rates are not fully promising. Less is known regarding the PAP adherence rates in Turkey. In the current study, the researchers primarily addressed if an intensified patient education strategy including the polysomnography (PSG) charts viewing followed by frequent follow-ups would improve the compliance rates at long-term in patients with OSA.

Detailed Description

OSA is a common disorder with serious complications. PAP is the first line treatment of OSA, but overall acceptance and adherence rates are not fully promising. In the current study, the researchers primarily addressed if an intensified patient education strategy including the PSG charts viewing followed by frequent follow-ups would improve the compliance rates at long-term in patients with OSA.

METHOD:

This single-center, randomized, controlled study was conducted at the Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital in Istanbul between June 2014 and April 2015. Eligible OSA patients were randomized to Standard Support (SS) group (general information about OSA and PAP treatment at baseline), or to Educational Support (ES) group (additional polysomnography chart viewing from both diagnostic and titration nights). All patients were scheduled to five PAP control visits between 2 weeks and 6 months after the PAP prescription. Primary outcome was the PAP compliance (4 h/night for 70% of all the nights) at the last visit.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Device and Standard Care	Active Comparator	Positive Airway Pressure Device and Standard Support	Other: Standard Support
Device and Educational Care	Active Comparator	Positive Airway Pressure Device and Educational Support	Other: Educational Support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Educational Support	Other	General information about OSA and PAP treatment at baseline and additional polysomnography chart viewing from both diagnostic and titration nights	Device and Educational Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive Airway Pressure usage (hours/night)	Satisfactory device usage defined as minimum 4 hours of night during at least 70% of period based on the objective measures from the device	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive adult patients with newly diagnosed obstructive sleep apnea (apnea-hypopnea index ≥5 events/h), who were offered PAP treatment.
Must be able to give informed consent

Exclusion Criteria:

Disabled to come to follow-ups.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sema Sarac, MD	Istanbul Sureyyapasa Chest Diseases and Chest Surgery Hospital	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014146	Training Support

Ancestor Terms

ID	Term
D005378	Financial Support
D004467	Economics
D004472	Health Care Economics and Organizations

Browse Leaves

Not provided

Browse Branches

Not provided