Obstructive Sleep Apnea in World Trade Center Responders

Obstructive Sleep Apnea Clinical Trial

Official title:

Obstructive Sleep Apnea in WTC Responders: Role of Nasal Pathology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753999
• Other study ID #: 2012002164
• Secondary ID: 1U01OH010415-01
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: March 2017

Study information

• Verified date: October 2020
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Standard CPAP
Use of the REMstar Auto A-Flex in standard CPAP therapy mode
• CPAP - Flex
Use of Philips Respironics REMstar Auto A-Flex in C-Flex mode

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York
United States	New York University School of Medicine Clinical Center of Excellence	New York	New York
United States	Environmental and Occupational Health Sciences Institute	Piscataway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to CPAP Overall Study, Subjects With High Nasal Resistance	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
Other	Adherence to CPAP Overall Study, Subjects With Low Nasal Resistance	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
Primary	Adherence to CPAP Pre-crossover	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
Primary	Adherence to CPAP Overall Study	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	CPAP Efficacy	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
Secondary	CPAP Efficacy	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