CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 317 enrolled
Drug / intervention
Standard CPAP +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01753999
NCT01753999N/ACompleted

Obstructive Sleep Apnea in WTC Responders: Role of Nasal Pathology

Rutgers, The State University of New Jersey·interventional·Posted Dec 21, 2012·Updated Apr 30, 2025

In Brief

A clinical study evaluating Standard CPAP and CPAP - Flex for Obstructive Sleep Apnea. Completed, enrolled 317 participants across 3 sites.

Detailed Summary

The goal of the study is to examine the possible underlying causes of sleep apnea (a disorder in which there are problems with breathing during sleep) in World Trade Center Responders. The study will look at the relationship between sleep apnea and various nose and throat conditions. Specifically, the study will look at upper airway disease (problems with the nose and throat), nasal inflammation, and nasal resistance (the amount of airflow through the nose). Subjects will have a physical exam and answer questions about nasal symptoms and sleeping problems. Nasal lavage (washing the inner nasal passages) will be performed on the subjects and markers of inflammation will be measured in the lavage fluid. Rhinomanometry (measuring the airflow through the nose) will also be performed to measure the degree of airflow obstruction. All subjects will be asked to perform in-home sleep apnea monitoring. Those subjects who are diagnosed with sleep apnea will test two treatment methods. Sleep apnea is treated by using a CPAP (continuous positive airway pressure) device. This device blows air into a mask worn by the patient during sleep. The two treatment methods that will be tested are the fixed pressure CPAP (pressure is constant during use) and CPAP-flex (pressure decreases when the subject exhales). Patients will be randomly assigned to one treatment method for one month then crossed to the other treatment method for the next month. The investigators will determine if patients with certain nasal conditions (high nasal resistance) are more likely to use CPAP-flex rather than CPAP.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNYU Langone Health

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2012
Enrollment StartDec 1, 2012
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.5 years ago

Interventions

Standard CPAPdevice

Use of the REMstar Auto A-Flex in standard CPAP therapy mode

CPAP - Flexdevice

Use of Philips Respironics REMstar Auto A-Flex in C-Flex mode