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N/A N=317 Randomized Triple-blind Treatment

Obstructive Sleep Apnea in World Trade Center Responders

Obstructive Sleep Apnea

Enrolled (actual)
317
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Adherence to CPAP Pre-crossover — 1; 0.89 Hours/night

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Standard CPAP (Device); CPAP - Flex (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Rutgers, The State University of New Jersey
Primary completion
Mar 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Adherence to CPAP Pre-crossover
1; 0.89
PRIMARY
Adherence to CPAP Overall Study
1.03; 0.8
SECONDARY
CPAP Efficacy
2.71; 2.94
SECONDARY
CPAP Efficacy
2.71; 2.94

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01753999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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