Obstructive Sleep Apnea Syndrome | Cost-utility Study of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome Patients
Obstructive Sleep Apnea Syndrome research study
What is the primary objective of this study?
The purpose of this study is to estimate the cost-utility of continuous positive airway pressure (CPAP) therapy in obstructive sleep apnea (OSA) patients in Sao Paulo city, Brazil, after 3 years of treatment and to estimate the cost-effectiveness of CPAP on the number of medical visits, hospitalizations, medical examinations, used medications, new case incidence and cost of traffic accidents and absence from work. It is also designed to estimate quality-adjusted extended years of life, and to assess cost-effects of the therapy (device, masks, supplies, maintenance/year for membership of professional consulting, electric power) on the cost-effectiveness
Who is eligible to participate?
Inclusion Criteria: - Both genders - Aged 30 to 70 years old - AHI > 30 events/hour Exclusion Criteria: - Patients residing in other cities and states other than São Paulo / SP / Brazil - Patients with no fixed residence - Previous CPAP contact
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Obstructive Sleep Apnea Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:CPAP S8- Scape / ResmedThe pressure for treatment is according to PSG titration
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
CPAP treatment1000 patients with 3-years CPAP treatment after a PSG titration
Start Date: March 2011
Completed Date: March 2014
Phase: Phase 4
Primary Outcome: costs of medical events post CPAP treatment
Secondary Outcome: Costs relative to CPAP treatment
Study sponsors, principal investigator, and references
Principal Investigator: Camila F Rizzi, PhD
Lead Sponsor: Associação Fundo de Incentivo à Pesquisa