Patient Education and PAP Compliance in OSA

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: Standard Support; Other: Educational Support

• Registration Number: NCT02756299
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-04
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-28
• Study First Posted: 2016-04-29
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device and Standard Care	Standard Support	Positive Airway Pressure Device and Standard Support
Device and Educational Care	Educational Support	Positive Airway Pressure Device and Educational Support

Primary Outcome Measures

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