Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Cost-Effectiveness of a Super Simplified System for the Management of Patients With Sleep Apneas in Primary Healthcare.
Brief Summary: Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.

Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.


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:

1. Snoring or apneas objectively observed during sleep by a partner;
2. Symptoms that are potentially secondary to apneas/hypopneas with an intermediate-high probability of being treated with CPAP. In operative terms, Epworth scale ≥12 or previous cardiovascular disease;
3. Age between 18 and 70 years;
4. Absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness.

Exclusion Criteria:

1. Psycho-physical incapacity to complete questionnaires;
2. Documented structural or coronary heart disease uncontrolled by any medical treatment;
3. Cheyne-Stokes syndrome;
4. Patients subjected to uvulopalatopharyngoplasty;
5. Significant nasal obstruction impeding the use of CPAP;
6. Pregnancy;
7. Lack of informed consent.
C: Inclusion criteria

Participants are included in the study if all of the following criteria are met:

(1) Are able to provide written informed consent by self or legally authorized representative. MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) will be used to assess decision making capacity; (2) OSA defined as an apnea-hypopnea index (AHI) ≥10, using either a clinical split- or whole-night polysomnography. We chose an AHI cut-off of ≥10 as opposed to ≥15, the conventional cut-off for moderate OSA because split-night studies underestimate the AHI; (3) education-adjusted scores of 28-35 on the modified Telephone Interview for Cognitive Status; (4) 0-0.5 on the Clinical Dementia Rating (CDR); (5) 24-30 on the Mini-Mental State Examination (MMSE); (6) memory impairment approximately 1.0-1.5 standard deviations below normal (adjusted for age and education), determined by scores on the Logical Memory II test; (7) performance approximately 1.0-1.5 standard deviations below normal (adjusted for age and education) in no more than one cognitive domain in addition to memory; (8) medications stable for at least 4 weeks; washout from psychoactive medications (e.g., excluded anti-depressants, neuroleptics, chronic anxiolytics, and sedative hypnotics) for 4 weeks; (9) score of ≤28 on the 21-item Beck Depression Inventory II; (10) a study partner who spends at least 10 hours per week in phone or in-person contact with participant; (11) visual and auditory acuity for testing; (12) 6 or more grades of education completed, or a history to exclude intellectual disability; and (13) English fluency.

Exclusion criteria

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

(1) significant neurologic disease other than MCI; (2) MRI exclusions, e.g. metal; (3) psychiatric disorders, including uncontrolled major depression, bipolar disorder, or schizophrenia; (4) history of alcohol dependence within 6 months; (5) current significant unstable medical condition; (6) participation in studies involving neuropsychological testing; (7) currently receiving CPAP; (8) requiring oxygen during CPAP; (9) dementia indicated by impairment in 3-5 age and education adjusted cognitive domains.
D: Inclusion Criteria:

* Physician diagnosis of obstructive sleep apnea syndrome plus polysomnography demonstrating greater than 10 apneas plus hypopneas per hour of sleep
* Age 18-80 years
* Ability to use a telephone without assistance

Exclusion Criteria:

N/A

Answer: B