Clinical trial NCT01753999: Obstructive Sleep Apnea in World Trade Center Responders
Official title: Obstructive Sleep Apnea in WTC Responders: Role of Nasal Pathology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: World Trade Center (WTC)
nasal symptoms
nasal inflammation
CPAP
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: NYU Langone Health
First posted: 2012-12-21
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Adherence to CPAP Pre-crossover
timeFrame: 5 weeks after initiation of treatment
measure: Adherence to CPAP Overall Study
timeFrame: 9 weeks after initiation of treatment
Secondary outcomes:
measure: CPAP Efficacy
timeFrame: 5 weeks after initiation of treatment
measure: CPAP Efficacy
timeFrame: 9 weeks after initiation of treatment
Other outcomes:
measure: Adherence to CPAP Overall Study, Subjects With High Nasal Resistance
timeFrame: 9 weeks after initiation of treatment
measure: Adherence to CPAP Overall Study, Subjects With Low Nasal Resistance
timeFrame: 9 weeks after initiation of treatment
Locations:
city: Piscataway
country: United States
facility: Environmental and Occupational Health Sciences Institute
state: New Jersey
city: New York
country: United States
facility: New York University School of Medicine Clinical Center of Excellence
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Rutgers RWJMS
name: Jag Sunderram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYUMC
name: Indu Ayappa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sunderram J, Ayappa I, Lu SE, Wang H, Black K, Twumasi A, Sanders H, Harrison D, Udasin I, Chitkara N, de la Hoz RE, Carson JL, Rapoport DM. PAP Adherence and Nasal Resistance. A Randomized Controlled Trial of CPAPflex versus CPAP in World Trade Center Responders. Ann Am Thorac Soc. 2021 Apr;18(4):668-677. doi: 10.1513/AnnalsATS.202009-1161OC.
citation: Ayappa I, Sunderram J, Black K, Twumasi A, Udasin I, Harrison D, Carson JL, Lu SE, Rapoport DM. A comparison of CPAP and CPAPFLEX in the treatment of obstructive sleep apnea in World Trade Center responders: study protocol for a randomized controlled trial. Trials. 2015 Sep 10;16:403. doi: 10.1186/s13063-015-0907-7.