Details:

Alternative Title:
Trials
Publisher's site:
http://dx.doi.org/10.1186/s13063-015-0907-7
Personal Author:
Ayappa, Indu ; Sunderram, Jag ; Black, Kathleen ; Twumasi, Akosua ; Udasin, Iris ; ... More +
Ayappa, Indu ; Sunderram, Jag ; Black, Kathleen ; Twumasi, Akosua ; Udasin, Iris ; Harrison, Denise ; Carson, Jeffrey L. ; Lu, Shou-En ; Rapoport, David M. Less -
Description:
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 (CPAPFlex) has been suggested to improve comfort without compromising efficacy. We will compare CPAP to CPAPFlex 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 CPAPflex, 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 CPAPFlex will improve adherence to CPAP in those subjects with high nasal resistance.

Trial Registration

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


Subjects:
[+]
Cflex Continuous Positive Airway Pressure CPAPFlex Nasal Resistance Obstructive Sleep Apnea Study Protocol World Trade Center
Source:
Trials. 16.
Pubmed ID:
26357928
Pubmed Central ID:
PMC4566493
Document Type:
Journal Article
Funding:
U01 OH010415/OH/NIOSH CDC HHS/United States
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:69cd0682282128b14b28575b55c4d54ef7c793eda4924e64e446ee4a947a2ce1
Download URL:
https://stacks.cdc.gov/view/cdc/34999/cdc_34999_DS1.pdf
File Type:

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