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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

Study Interventions

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

Study Arms

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

Study Status

Unknown status

Start Date: March 2011

Completed Date: March 2014

Phase: Phase 4

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01590420

Discuss Camila