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Obstructive Sleep Apnea in World Trade Center Responders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01753999
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : July 20, 2018
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
NYU Langone Health
Information provided by (Responsible Party):
Jag Sunderram, MD, Rutgers, The State University of New Jersey

Brief 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Standard CPAP Device: CPAP - Flex Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Obstructive Sleep Apnea in WTC Responders: Role of Nasal Pathology
Actual Study Start Date : December 2012
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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 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




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753999


Locations
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United States, New Jersey
Environmental and Occupational Health Sciences Institute
Piscataway, New Jersey, United States, 08854
United States, New York
New York University School of Medicine Clinical Center of Excellence
New York, New York, United States, 10016
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Rutgers, The State University of New Jersey
NYU Langone Health
Investigators
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Principal Investigator: Jag Sunderram, MD Rutgers RWJMS
Principal Investigator: Indu Ayappa, PhD NYUMC
  Study Documents (Full-Text)

Documents provided by Jag Sunderram, MD, Rutgers, The State University of New Jersey:
Study Protocol  [PDF] May 18, 2016
Statistical Analysis Plan  [PDF] January 3, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jag Sunderram, MD, Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01753999    
Other Study ID Numbers: 2012002164
1U01OH010415-01 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2012    Key Record Dates
Results First Posted: July 20, 2018
Last Update Posted: November 4, 2020
Last Verified: October 2020
Keywords provided by Jag Sunderram, MD, Rutgers, The State University of New Jersey:
World Trade Center (WTC)
nasal symptoms
nasal inflammation
CPAP
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases