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Obstructive Sleep Apnea in World Trade Center Responders

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Rutgers, The State University of New Jersey
Sponsor:
Collaborator:
New York University School of Medicine
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01753999
First received: December 17, 2012
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Device: Standard CPAP
Device: CPAP - Flex

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Obstructive Sleep Apnea in WTC Responders: Role of Nasal Pathology

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Adherence to CPAP [ Time Frame: 9 weeks after initiation of treatment ] [ Designated as safety issue: No ]
    The use (number of hours per night) will be compared between standard CPAP and CPAP flex.


Secondary Outcome Measures:
  • CPAP Efficacy [ Time Frame: 9 weeks after initiation of treatment ] [ Designated as safety issue: No ]
    Efficacy will be evaluated by measuring the apnea and hypopnea index (AHI)during treatment. The efficacy of standard CPAP and CPAP flex will be compared.


Estimated Enrollment: 440
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Philips Respironics REMstar Auto A-Flex

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 or the New York University School of Medicine Clinical Center of Excellence at Bellevue Hospital in New York, NY.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753999

Locations
United States, New Jersey
Environmental and Occupational Health Sciences Institute Recruiting
Piscataway, New Jersey, United States, 08854
Contact: Kathy Black, PhD    848-445-6049    kgblack@eohsi.rutgers.edu   
Sub-Investigator: Iris Udasin, MD         
United States, New York
New York University School of Medicine Clinical Center of Excellence Recruiting
New York, New York, United States, 10016
Contact: Indu Ayappa, PhD    212-562-8437    indu.ayappa@nyumc.org   
Sub-Investigator: Denise Harrison, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
New York University School of Medicine
Investigators
Principal Investigator: Jag Sunderram, MD Rutgers RWJMS
Principal Investigator: Indu Ayappa, PhD NYUMC
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01753999     History of Changes
Other Study ID Numbers: 2012002164, 1U01OH010415-01
Study First Received: December 17, 2012
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
World Trade Center (WTC)
nasal symptoms
nasal inflammation
CPAP

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 27, 2014