Patient Education and PAP Compliance in OSA

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient Education and PAP Compliance in OSA

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: Educational Support
* Other: Standard Support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device and Standard Care<br>Positive Airway Pressure Device and Standard Support | Other: Standard Support<br>* General information about OSA and PAP treatment at baseline<br>|
| Active Comparator: Device and Educational Care<br>Positive Airway Pressure Device and Educational Support | Other: Educational Support<br>* General information about OSA and PAP treatment at baseline and additional polysomnography chart viewing from both diagnostic and titration nights<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Apnea, Positive Airway Pressure, Patient Education