Patient Education and PAP Compliance in OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

Patient Education and PAP Compliance in OSA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756299
• Other study ID #: 89513307/1009/309
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: April 28, 2016
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2016
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Other:
• Educational Support
General information about OSA and PAP treatment at baseline and additional polysomnography chart viewing from both diagnostic and titration nights
• Standard Support
General information about OSA and PAP treatment at baseline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No