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Patient Education and PAP Compliance in OSA

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational Support
Standard Support
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring Sleep Apnea, Positive Airway Pressure, Patient Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Device and Standard Care

    Device and Educational Care

    Arm Description

    Positive Airway Pressure Device and Standard Support

    Positive Airway Pressure Device and Educational Support

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 25, 2016
    Last Updated
    April 28, 2016
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02756299
    Brief Title
    Patient Education and PAP Compliance in OSA
    Official Title
    Patient Education and PAP Compliance in OSA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marmara University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea
    Keywords
    Sleep Apnea, Positive Airway Pressure, Patient Education

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    115 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Device and Standard Care
    Arm Type
    Active Comparator
    Arm Description
    Positive Airway Pressure Device and Standard Support
    Arm Title
    Device and Educational Care
    Arm Type
    Active Comparator
    Arm Description
    Positive Airway Pressure Device and Educational Support
    Intervention Type
    Other
    Intervention Name(s)
    Educational Support
    Intervention Description
    General information about OSA and PAP treatment at baseline and additional polysomnography chart viewing from both diagnostic and titration nights
    Intervention Type
    Other
    Intervention Name(s)
    Standard Support
    Intervention Description
    General information about OSA and PAP treatment at baseline
    Primary Outcome Measure Information:
    Title
    Positive Airway Pressure usage (hours/night)
    Description
    Satisfactory device usage defined as minimum 4 hours of night during at least 70% of period based on the objective measures from the device
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sema Sarac, MD
    Organizational Affiliation
    Istanbul Sureyyapasa Chest Diseases and Chest Surgery Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Patient Education and PAP Compliance in OSA

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