Please select the eligibility criteria that correspond to the clinical trial below.
Title: Obstructive Sleep Apnea in WTC Responders: Role of Nasal Pathology
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.


Options:
A: Inclusion Criteria:

* patient with OSA (AHI ≥20 / h)
* patient with daytime sleepiness
* naive of any pressure treatment of OSA
* patient able to provide written informed consent
* not a vulnerable person or legally protected adult.

Exclusion Criteria:

* pregnancy
* Person deprived of liberty or subject to a legal protection measure.
* Patient with serious heart failure (According to investigator judgment)
* patient with central sleep apnea index above 20% of AHI
* Patient with a significant intercurrent pathology that can influence the results. (According to investigator judgment).
B: Inclusion Criteria:

* Age 21 - 75
* Diagnosis of OSAHS with baseline AHI (Apnea-Hypopnea Index) equal or greater than 15 events/hr of sleep
* Able and willing to provide written informed consent
* Agreement to try PAP (positive airway pressure) as initial treatment approach
* Adequate clinical CPAP titration within two weeks of enrollment

Exclusion Criteria:

* Participation in another interventional research study within the last 30 days
* The need for more than one titration PSG (polysomnography)
* The use of sedatives or hypnotics during the titration PSG
* Major medical or psychiatric condition that would interfere with the demands of the study, adherence to PAP or the ability to commit to follow-up assessment.
* Prior prescription for, or exposure to PAP therapy within the previous year (except exposure to CPAP during clinical therapy titration.)
* Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD (chronic obstructive pulmonary disease) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\>45 mmHG) while awake or participants qualifying for oxygen therapy (arterial saturation \< or equal to 88% for more than five minutes).
* Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
* Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)
* Presence of untreated or poorly managed, non-OSAHS related sleep disorders:

  * moderate to severe periodic limb movements (greater or equal to 15 per hour with symptoms or arousals)
  * Restless Leg syndrome (greater than 10 per hour)
  * Males experiencing chronic insomnia
* Use of medications with hypnotic or sedative effects or regular use of night time sedatives or sleeping aids greater than or equal to one night per week.
* Consumption of ethanol more than 4 nights per week (CAGE criteria)
* Shift workers
C: 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.
D: Inclusion Criteria:

* Age between 15 and 80 years old.
* Absence of moderate or severe chronic obstructive pulmonary disease (COPD).
* Absence of neuromuscular, chest wall or metabolic disease which cause daytime hypercapnia.
* Absence of narcolepsy or restless legs syndrome
* Exceed correctly treatment of at least 30 minutes with CPAP/NIV at wakefulness.

Exclusion Criteria:

* Psychophysical incapacity to answer questionnaires.
* Patients who are not able to be evaluated by means of quality of life questionnaires for suffering restrictive chronic disease previously diagnosed (neoplasy, chronic pain of any origin, renal failure, severe chronic obstructive pulmonary disease and any other restrictive chronic disease).
* Subjects with important chronic nasal obstruction that prevents from using CPAP/NIV.
* Informed consent not obtained.

Answer: C