Obstructive Sleep Apnea in World Trade Center Responders

October 10, 2020 updated by: Jag Sunderram, MD, Rutgers, The State University of New Jersey

Obstructive Sleep Apnea in WTC Responders: Role of Nasal Pathology

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following the World Trade Center (WTC) disaster, an estimated 40,000 individuals were exposed to significant amounts of dust while working in rescue, recovery and debris removal. A significant number of these responders have reported least one new or worsened upper airway respiratory symptom when examined in 2004 with 50% of responders continuing to have symptoms of chronic rhino-sinusitis or upper airway disease (UAD) in 2007. In addition, about 50% of those with UAD referred to our sleep center reported new onset snoring on their questionnaires immediately following their exposure and had unusually high prevalence of obstructive sleep apnea (OSA) that did not appear to be related to obesity, which is the usual risk factor for OSA. This suggests to us that mechanisms other than obesity may be important in the pathogenesis of OSA in these subjects. Given their chronic nasal symptoms they also provide a unique opportunity to examine the relationship between nasal pathology and OSA and test if nasal symptoms reported by the subjects in the WTC Health Program (WTCHP) are an indicator of increased nasal resistance due to nasal inflammation resulting from exposure to the WTC dust. Positive Airway Pressure (CPAP) is the standard therapy for OSA but despite its efficacy has poor adherence. Subjects with high nasal resistance (such as responders with UAD and OSA) may experience additional pressure during expiration at the upper airway resulting in greater difficulty in tolerating CPAP therapy than those who do not have high nasal resistance. Reduction of excess expiratory positive pressure by the modality known as Cflex™ during CPAP therapy (CPAPFlex) may improve comfort and adherence in these subjects without compromising CPAP efficacy. In the present proposal we will study responders enrolled at the Environmental and Occupational Health Sciences Institute of Robert Wood Johnson Medical School (RWJMS) and the NYU School of Medicine Clinical Center of Excellence at Bellevue Hospital

Study Type

Interventional

Enrollment (Actual)

317

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Environmental and Occupational Health Sciences Institute
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10016
        • New York University School of Medicine Clinical Center of Excellence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Member of the World Trade Center Health Program at either the Environmental and Occupational Healthy Sciences Institute at Robert Wood Johnson Medical School in Piscataway, NJ, the New York University School of Medicine Clinical Center of Excellence at Bellevue Hospital in New York, NY, or the Icahn School of Medicine at Mount Sinai.

Exclusion Criteria:

  • Gross skeletal alterations affecting the upper airway (nose and throat)
  • Unstable chronic medical conditions known to affect Obstructive Sleep Apnea (congestive heart failure, stroke)
  • Pregnancy or intent to become pregnant
  • Habitual snoring or diagnosis of obstructive sleep apnea prior to 9/11/2001.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard CPAP
Use of a standard CPAP (continuous positive airway pressure) device with constant pressure for 4 weeks to improve breathing during sleep
Device: Standard CPAP
Use of the REMstar Auto A-Flex in standard CPAP therapy mode
Other Names:
  • Philips Respironics REMstar Auto A-Flex
Active Comparator: CPAP - Flex
Use of CPAP-Flex (continuous positive airway pressure) device with decreased pressure during expiration for 4 weeks to improve breathing during sleep
Device: CPAP - Flex
Use of Philips Respironics REMstar Auto A-Flex in C-Flex mode
Other Names:
  • Philips Respironics REMstar Auto A-Flex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to CPAP Pre-crossover
Time Frame: 5 weeks after initiation of treatment
The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on the first treatment period only (pre-crossover).
5 weeks after initiation of treatment
Adherence to CPAP Overall Study
Time Frame: 9 weeks after initiation of treatment
The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on both periods.
9 weeks after initiation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAP Efficacy
Time Frame: 5 weeks after initiation of treatment
Efficacy will be evaluated by measuring the residual apnea and hypopnea index (AHI) while on treatment. The efficacy of standard CPAP and CPAP-flex will be compared. Results are based on the first treatment period only (pre-crossover).
5 weeks after initiation of treatment
CPAP Efficacy
Time Frame: 9 weeks after initiation of treatment
Efficacy will be evaluated by measuring the residual apnea and hypopnea index (AHI) while on treatment. The efficacy of standard CPAP and CPAP-flex will be compared. Results are based on both treatment periods.
9 weeks after initiation of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to CPAP Overall Study, Subjects With High Nasal Resistance
Time Frame: 9 weeks after initiation of treatment
The use (number of hours per night) will be compared between standard CPAP and CPAP flex for subjects with high total nasal resistance (logTNR>0.8). The analysis is based on both periods.
9 weeks after initiation of treatment
Adherence to CPAP Overall Study, Subjects With Low Nasal Resistance
Time Frame: 9 weeks after initiation of treatment
The use (number of hours per night) will be compared between standard CPAP and CPAP flex for subjects with low total nasal resistance (logTNR<=0.8). The analysis is based on both periods.
9 weeks after initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

NYU Langone Health

Investigators

  • Principal Investigator: Jag Sunderram, MD, Rutgers RWJMS
  • Principal Investigator: Indu Ayappa, PhD, NYUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

December 17, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

October 10, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012002164
  • 1U01OH010415-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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