Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea

Overview

OBJECTIVES: To evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with continuous positive airway pressure (CPAP) in patients with moderate positional obstructive sleep apnea (POSA). HYPOTHESIS: The SPT+MAD combination is more cost-effective and effective, in means of reduction of the apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP. STUDY DESIGN: A multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12 months per patient. Patients will be randomized for CPAP or the combination SPT and MRA. All outcomes will be measured at baseline, month 3, 6 and 12. STUDY POPULATION: Patients diagnosed with moderate POSA according to polysomnography (PSG) results. INTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO: The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a protrusive position, all to prevent effectively apneic events. OUTCOME MEASURES: AHI, compliance, quality-adjusted life year (QALY), direct and indirect costs, cardiovascular parameters, incremental cost-effectiveness ratio (ICER) SAMPLE SIZE / DATA ANALYSIS: 100 subjects in each treatment group, total of 200 patients. COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS: The SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients, and will save annually approximately 35-150 million euros.

Conditions