Please select the eligibility criteria that correspond to the clinical trial below.
Title: Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hypoventilation Syndrome
Brief Summary: Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus continuous positive airway pressure (CPAP) and life style modification treatment in Obesity Hypoventilation Syndrome (OHS), with PCO2 (first phase) and days of hospitalization (second phase) analyzed as a primary variables and percentage of dropouts for medical reasons and mortality as operative variables. As secondary variables: Measure functional and clinical improvement during sleep and wakefulness, quality of life, echocardiography and the incidence and blood pressure and evolution of cardiovascular events. Objectives secondaries:role of apneogenic sleep events on molecular inflammation, endothelial damage and the genesis of diurnal hypercapnia. Methods:prospective, randomized controlled trial. Patients with OHS will be divided initially into two groups based on their apnea-hypopnea index (AHI) score, \>=30 and \< 30, using conventional polysomnography. The AHI \>=30 group will be randomized to CPAP, NIV or life style modification treatments. The AHI \<=30 groups will be randomized to NIV or life style modification treatments. Treatment efficacy at the medium- and long-term will be analyzed by comparing groups. The role of apneic events and leptin in the genesis of daytime alveolar hypoventilation will be analyzed by comparing the daytime PCO2/AHI coefficient between responders and non-responders to CPAP treatment, and the evolution of leptin levels in the four branches of the study. The role of apneic events in metabolic and biochemical alterations and endothelial dysfunction will be analyzed by comparing basal and post-treatment levels of related substances between groups, with and without significant AHI.


Options:
A: Inclusion Criteria:

1. Males and females, any race, and aged between 45 and 75 years
2. Evidence of established coronary or cerebrovascular disease as evident by:

   * Coronary artery disease

     * Previous MI (equal to or greater than 90 days prior to ApneaLinkTM assessment)
     * Stable angina or unstable angina (Clinical event equal to or greater than 30 days and confirmatory test equal to or greater than 7 days prior to ApneaLinkTM assessment) defined as either ≥70% diameter stenosis of at least one major epicardial artery segment, or ≥50% diameter stenosis of the left main coronary artery, or \>50% stenosis in at least two major epicardial arteries.; or positive stress test (ST depression equal to or greater than 2 mm or a positive nuclear perfusion scintigram)
     * Multi-vessel percutaneous angioplasty (PTCA) and/or stent equal to or greater than 90 days prior to ApneaLinkTM assessment
     * Multi-vessel coronary artery bypass surgery (CABG) \>1 year prior to ApneaLinkTM assessment
   * Cerebrovascular disease

     * Previous stroke (includes definite or presumed cerebral ischaemia/infarction and intracerebral but not subarachnoid haemorrhage) equal to or greater than 90 days prior to ApneaLinkTM assessment or minor disabling stroke with minimal residual neurological disability (modified Rankin Score of '0 = no symptoms' or '1 = No significant disability despite symptoms, able to carry out all usual duties and activities' within 7 days of stroke onset) ≥7 days prior to ApneaLinkTM assessment.
     * Previous transient ischaemic event (TIA) of the brain or retina (symptoms \<24 hours) but not of presumed vertebrobasilar system ischemia. The TIA diagnosis must be confirmed by a suitably qualified clinician (≥7 days but \<1year prior to ApneaLinkTM assessment)
3. Patients have moderate-severe OSA (equivalent to apnea plus hypopneas index \[AHI\] \>30 per hour of sleep) as determined by a ≥ 4% oxygen dip rate \> 12/ h on overnight testing using the ApneaLinkTM device and confirmed by the SAVE core lab in Adelaide upon receipt of the ApneaLinkTM data
4. Patients are able and willing to give appropriate informed consent

Exclusion Criteria:

Patients will be excluded from entry if ANY of the criteria listed below are met:

1. Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study. For example,

   * co-morbid disease with severe disability or likelihood of death
   * significant memory, perceptual, or behavioural disorder
   * neurological deficit (e.g. limb paresis) preventing self administration of the CPAP mask
   * contraindication to CPAP use e.g. pneumothorax
   * residence sufficiently remote from the clinic to preclude follow-up clinic visits
2. Any planned coronary or carotid revascularisation procedure in the next 6 months
3. Severe respiratory disease defined as

   * severe chronic obstructive pulmonary disease (FEV1/FVC \< 70% and FEV1 \< 50% predicted), or
   * resting, awake SaO2 \< 90% by ApneaLinkTM device
4. New York Heart Association (NYHA) categories III-IV of heart failure
5. Other household member enrolled in SAVE trial or using CPAP
6. Prior use of CPAP treatment for OSA
7. Increased risk of a sleep-related accident and/or excessive daytime sleepiness, defined by any one of the following:

   * driver occupation (eg truck, taxi)
   * 'fall-asleep' accident or 'near miss' accident in previous 12 months
   * high (\> 15) score on the Epworth Sleepiness Scale
8. Severe nocturnal desaturation documented on the ApneaLinkTM device as \> 10% overnight recording time with arterial oxygen saturation of \< 80%
9. Cheyne-Stokes Respiration (CSResp)

   * CSResp identified on ApneaLinkTM nasal pressure recording by typical crescendo-decrescendo pattern of respiration with associated apneas and/or hypopneas in the absence of inspiratory flow limitation.
   * patients excluded if \> 50% of nasal pressure - defined apneas and hypopneas judged to be due to CSResp.
B: 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.
C: 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
D: Inclusion Criterion:

1. Age 21-75
2. New Diagnosis of OSA with a baseline RDI ≥ 15 events/hr of sleep determined by either full night or split night PSG
3. Able and willing to provide written informed consent
4. Able to follow study procedures
5. Sub-optimal PSG titration with at least 3 hours of attempted PAP titration (defined below): and deemed by their physician as a titration failure

Sub-optimal PSG titration: at least one of the following:

1. Poor sleep efficiency during titration period (sleep efficiency ≤ 70%) (participants may be on sleep medications as per standard lab CPAP protocol ) or;
2. Frequent arousals based on three seconds of alpha frequency on EEG (non PLM-related) of 20 or greater per hour during the titration portion of the study or;
3. CPAP titration aborted due to participant's request (due to intolerance), or
4. Persistent sleep disruption despite therapeutic CPAP therapy and in the judgment of the reviewing physician, suggesting a low probability to CPAP adherence

Exclusion Criterion:

1. Participation in another interventional research study within the last 30 days
2. Major uncontrolled medical or psychiatric condition such as congestive heart failure, neuromuscular disease, renal failure etc.
3. Prior CPAP or Bi-Level PAP use (within last 2 years)
4. Chronic respiratory failure or insufficiency, moderate COPD (FEV1 \< 60%), or any known condition of an elevation of arterial carbon dioxide levels while awake
5. Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
6. Presence of an untreated, diagnosable, non-OSA related sleep disorder (e.g. restless legs syndrome, insomnia, etc.)
7. Periodic Limb movement arousal index of 10 or greater.
8. Refusal to consider further interventions to standard CPAP to optimize positive pressure therapy (e.g. different mask than what was used in lab)
9. PAP therapy otherwise medically complicated or contraindicated such as those with a difficult to size or adjust interface (mask) resulting in facial pain, skin irritation or trauma, or excessive air leaks
10. Shift workers or people experiencing jet lag
11. Known history of alcohol and or drug abuse
12. Diagnosis of Complex Sleep Apnea, (appears to be classic obstructive or mixed sleep apnea, but exhibits disruptive central apneas and periodic breathing on CPAP) 11, 12 or persistent central apnea during diagnostic PSG.
13. Diagnosis of Attention Deficit Hyperactivity Disorder
14. Chronic Hypnotic use (nightly use for three months or less)

Answer: B