Cost-utility Study of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome Patients

Associação Fundo de Incentivo à Pesquisa

Status and phase: Unknown; Phase 4

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: CPAP S8- Scape / Resmed

Study type: Interventional

Funder types: Other

Identifiers

NCT01590420

Cost-utility of OSAS

Details and patient eligibility

About

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

Full description

OSA is highly prevalent in Sao Paulo city, Brazil. It is associated with significant comorbidities. The cost-utility study is important to (1) support decision-making on health policies, (2) to incorporate new technologies, (3) implementation of preventive programs and policy development assistance in the medical field.

Probably CPAP treatment in the long-term, will improve health, physical and mental state, and especially, reduces spending on public health, demonstrating cost-utility.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

CPAP treatment

Experimental group

Description:

1000 patients with 3-years CPAP treatment after a PSG titration

Treatment:

Device: CPAP S8- Scape / Resmed