Please select the eligibility criteria that correspond to the clinical trial below.
Title: CPAP Treatment : Fixed Versus Auto-adjusting Mode Impact on Clinical Blood Arterial Pressure. Randomised, Controlled and Double Blinded Trial in SAOS Patients
Brief Summary: Background: Continuous positive airway pressure (CPAP) is the first line therapy for obstructive sleep apnea syndrome (OSAS). Two positive airway pressure (PAP) modalities can be used: Fixed pressure, in which the effective pressure is set and kept constant all night, and auto CPAP devices where the positive pressure changes during the night depend on patient's requirements.

Hypothesis: Pressure variations associated with autoCPAP functioning can lead to sleep fragmentation and alterations in sleep structure. This can limit blood pressure dipping during sleep and then impact clinical blood pressure reduction.

Main objective: To compare in a randomized controlled trial 4 months clinical blood pressure (BP) evolution depending on CPAP mode: fixed pressure versus autoCPAP. Secondary outcomes: Evolution of arterial stiffness, biological parameters, quality of life and symptoms.

Methods: Patients will be randomised depending on CPAP mode. Baseline and 4 months evaluation will include: 24-h ambulatory blood pressure monitoring, clinical BP measurements and carotid-to-femoral pulse wave velocity (PWV). Patients will also complete quality of life and symptoms questionnaires.

2 interim analysis will be carried out when 150 and 220 patients respectively will have completed the study. The Peto's method will be used to correct the p-values.


Options:
A: Inclusion Criteria:

* Willingness to provide written informed consent
* Patients who are using a ResMed mask system
* Patients who are at least 18 years of age
* Patients who use a ResMed CPAP device

Exclusion Criteria:

* Patients currently using Bilevel PAP
* Patients who are pregnant
* Patients who the researcher believes are unsuitable for inclusion because either:

  * they do not comprehend English
  * they are unable to provide written informed consent
  * they are physically unable to comply with the protocol
B: Inclusion Criteria:

* age between 18 and 80 years
* patients who gave written informed consent
* patients who subscribed a social insurance
* SAOS patients who need CPAP treatment.

Exclusion Criteria:

* cardiac failure known and treated
* central Apnea syndrome
* patients who stopped CPAP treatment in the previous year
* pregnant women
* patients under guardianship
* imprisoned patients, patients in hospital
* patients included in an other clinical study
C: Inclusion Criteria:

* Excessive sleepiness, and Epworth Sleepiness Score \> or = 8
* Apnea- Hypopnea-Index (AHI) \> or = 10/hour
* Age 18-75

Exclusion Criteria:

* Psychophysiological incapacity to perform questionnaires
* Other sleep disorders
* Psychiatric disease requiring treatment
* Previous CPAP therapy
* Previous uvulopalatopharyngoplasty
* Chronic nasal obstruction that required treatment for more than 1 month
* Cancer
* COPD, with FEV1 \< 50% predicted
* Symptomatic cardiovascular disease requiring treatment defined as congestive heart failure \> NYHA II
* Previous stroke with neurological residuum
* Cheyne-Stokes respiration
* Chronic pain syndromes, fibromyalgia
* Drug or alcohol addiction
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: B