Patient Education and PAP Compliance in OSA

NCT02756299 | Completed

• 1 other identifier: 89513307/1009/309
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea

Keywords

Sleep Apnea; Positive Airway Pressure; Patient Education

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Device and Standard Care

ACTIVE COMPARATOR

Positive Airway Pressure Device and Standard Support

Other: Standard Support

Device and Educational Care

ACTIVE COMPARATOR

Positive Airway Pressure Device and Educational Support

Other: Educational Support

Interventions

Educational Support OTHER

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

Device and Educational Care

Standard Support OTHER

General information about OSA and PAP treatment at baseline

Device and Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Disabled to come to follow-ups.

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Training Support

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Financial Support; Economics; Health Care Economics and Organizations

Study Officials

• Sema Sarac, MD

  Istanbul Sureyyapasa Chest Diseases and Chest Surgery Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 29, 2016
• Study Start: June 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 2, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share