Obstructive Sleep Apnea in World Trade Center Responders
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 11/18/2018 |
| Start Date: | December 2012 |
| End Date: | March 2017 |
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.
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.
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
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
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.
We found this trial at
2
sites
New York, New York 10016
Phone: 212-562-8437
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Piscataway, New Jersey 08854
Phone: 848-445-6049
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