Patient Education and PAP Compliance in OSA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-04-30

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.

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Device and Standard Care

Positive Airway Pressure Device and Standard Support

Group Type ACTIVE_COMPARATOR

Standard Support

Intervention Type OTHER

General information about OSA and PAP treatment at baseline

Device and Educational Care

Positive Airway Pressure Device and Educational Support

Group Type ACTIVE_COMPARATOR

Educational Support

Intervention Type OTHER

General information about OSA and PAP treatment at baseline and additional polysomnography chart viewing from both diagnostic and titration nights

Interventions

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Educational Support

General information about OSA and PAP treatment at baseline and additional polysomnography chart viewing from both diagnostic and titration nights

Intervention Type OTHER

Standard Support

General information about OSA and PAP treatment at baseline

Intervention Type OTHER

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