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Open Access 01-12-2015 | Study protocol

A comparison of CPAP and CPAP_FLEX in the treatment of obstructive sleep apnea in World Trade Center responders: study protocol for a randomized controlled trial

Authors: Indu Ayappa, Jag Sunderram, Kathleen Black, Akosua Twumasi, Iris Udasin, Denise Harrison, Jeffrey L. Carson, Shou-En Lu, David M. Rapoport

Published in: Trials | Issue 1/2015

Abstract

Background

Following the World Trade Center disaster, a large number of individuals involved in rescue and recovery activity were exposed to significant amounts of dust, and reported symptoms of chronic nasal and sinus inflammation. An unusually high prevalence of obstructive sleep apnea (OSA) has also been observed in this World Trade Center Responder population. This project aims to examine the relationship between nasal pathology and OSA. Our hypothesis is that increased nasal resistance due to nasal inflammation predisposes to OSA in this population. Continuous Positive Airway Pressure (CPAP) is the standard therapy for OSA but despite its efficacy has poor adherence. Subjects with high nasal resistance may have greater difficulty in tolerating this therapy than those who do not have high nasal resistance. Reduction of excess expiratory positive pressure by the modality known as Cflex™ during Continuous Positive Airway Pressure therapy (CPAP_Flex) has been suggested to improve comfort without compromising efficacy. We will compare CPAP to CPAP_Flex in subjects with OSA.

Study Design

Subjects with new onset habitual snoring will be screened for OSA using home sleep studies and rhinomanometry will be used to determine nasal resistance. In 400 subjects with OSA we will perform a randomized double blind cross-over study comparing CPAP to CPAP_flex, and relate nasal resistance to adherence to CPAP therapy.

Discussion

This is the first multicenter trial designed to test the hypothesis that adherence to CPAP therapy relates to nasal resistance and CPAP_Flex will improve adherence to CPAP in those subjects with high nasal resistance.

We anticipate the following results from this trial: 1. Increased nasal resistance is associated with decreased adherence to CPAP therapy. 2. Use of CPAP_Flex improves adherence with CPAP therapy in subjects with high nasal resistance, but not in those with low nasal resistance. 3. The benefit of CPAP_Flex on adherence is greatest when offered at CPAP therapy initiation rather than as a “rescue” therapy in subjects with high nasal resistance.

Trial Registration

ClinicalTrials.gov Identifier: NCT01753999, Date: 12 December 2012

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Title: A comparison of CPAP and CPAPFLEX in the treatment of obstructive sleep apnea in World Trade Center responders: study protocol for a randomized controlled trial
Authors: Indu Ayappa
Jag Sunderram
Kathleen Black
Akosua Twumasi
Iris Udasin
Denise Harrison
Jeffrey L. Carson
Shou-En Lu
David M. Rapoport
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-015-0907-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A comparison of CPAP and CPAP_FLEX in the treatment of obstructive sleep apnea in World Trade Center responders: study protocol for a randomized controlled trial

Abstract

Background

Study Design

Discussion

Trial Registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Study Design

Discussion

Trial Registration

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