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
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
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
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
Learn more about this trial
Patient Education and PAP Compliance in OSA
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