Please select the eligibility criteria that correspond to the clinical trial below.
Title: Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure Compliance: The Greek Experience
Brief Summary: The purpose of this study was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.


Options:
A: Inclusion Criteria:

* Obstructive apnea hypopnea index (AHI) ≥ 15
* Age 45-75 years, or 55 to 75 yrs if without established Cardiovascular Disease (CVD)
* Ability to provide informed consent, with the patient and physician acknowledging accepting uncertainty on the role of PAP in CVD prevention.
* Established CVD,or having diabetes mellitus, defined by one or more of the following:

  1. Prior myocardial infarction
  2. Coronary artery revascularization procedure (≥4 months before study entry)
  3. Angiographically documented stenosis (\>70%) of a major coronary artery
  4. Prior ischemic stroke without major functional impairment
  5. Diabetes mellitus treated with medication or ≥ 2 fasting glucose levels ≥ 126 mg/dl

OR

Three or more of the following established CVD risk factors:

1. Hypertension treated with medications or systolic BP \> 140 or diastolic BP \> 90 on ≥ 2 occasions
2. Male sex
3. BMI ≥ 30
4. Total cholesterol \> 240 mg/dl or LDL cholesterol \> 160 mg/dl or HDL \< 45 mg/dl
5. \> 10 pack years of smoking

Exclusion Criteria:

* Diagnosed heart failure with known cardiac ejection fraction of \< 35% or New York Heart Association (NYHA) class 3 or 4 status
* Less than 4 months since myocardial infarction (MI), stroke or revascularization procedure
* Poorly controlled hypertension (\>170/\>100)
* Prior stroke with functional impairment interfering with ability to complete the protocol
* Severe uncontrolled medical problems or medications that may influence measurements or impair ability to participate in the study exams (e.g. oral steroids; chronic opioid use; self- reported chronic kidney disease or, if measured, creatinine \> 2.5 mg/dl or glomerular filtration rate (GFR) \< 30; anemia with Hgb \< 10, etc.)
* Resting oxygen saturation \< 90% or nocturnal oxygen saturation \<85% for \> 10% of the sleep period;
* Use of prescribed PAP for sleep apnea within the prior 2 years
* Report of inability to spend \>6 hrs in bed
* Any use of prescribed PAP for sleep apnea
* Severe sleepiness defined by an Epworth Sleepiness Score of \>14 or report of falling asleep driving in the prior 2 years
* Working as a professional driver
* Low risk related to having sleep apnea defined by a Berlin Score \< 2
* Central sleep apnea, with \>50% of respiratory events classified as central apneas
* Refusal to consider PAP use after an initial split-night PAP study (pre-randomization)
* Concurrent involvement in another research study that will result in a conflict as determined by study doctors
B: Inclusion Criteria:

* Adult patients
* Newly diagnosed with OSA who are prescribed CPAP therapy

Exclusion Criteria:

* Patients \< 18 years old
* Patients over 65 years
* Pregnant women
* Patients with chronic liver disease
* Patients who abuse alcohol
* Patients taking narcotics or using sedative-hypnotic agents such as Ambien, Klonopin or Benadryl
C: Inclusion Criteria:

* newly diagnosed obstructive sleep apnea syndrome by polysomnography according to standard criteria,
* with moderate to severe sleep apnea,
* no history of previously CPAP therapy and
* with an above-elementary school education.

Exclusion Criteria:

* refusal to participate,
* refusal to CPAP therapy,
* previous CPAP treatment,
* central sleep apnoea syndrome,
* Cheyne-stokes breathing pattern,
* obesity hypoventilation syndrome,
* restrictive ventilator syndromes,
* congestive heart failure,
* history of life-threatening arrhythmias,
* cardiomyopathy,
* long term oxygen therapy,
* family or personal history of mental illness,
* with drug or alcohol abuse,
* severe cognitive impairment,
* concurrent oncologic diseases and
* history of narcolepsy.
D: 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

Answer: C