Obstructive Sleep Apnea Syndrome Clinical Trial
Official title:
Efficacy and Cost-Effectiveness of a Super Simplified System for the Management of Patients With Sleep Apneas in Primary Healthcare.
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.
Design: prospective, randomized, controlled, open, parallel, non-inferiority. A total of 280 patients will be randomized for management on the basis of DNP (primary) or PSG (specialist), thereby giving rise to 4 groups: two treated and two not treated with CPAP. The former will undergo a home auto-titration. The follow-up will last 6 months and include 4 evaluations. ;
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