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

Phase 4

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Device: CPAP S8- Scape / Resmed

• Registration Number: NCT01590420
• Lead Sponsor: Associação Fundo de Incentivo à Pesquisa

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-03
• Status Verified: 2012-05
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-02
• Last Update Submitted: 2012-05-02
• Study First Posted: 2012-05-03
• Last Update Posted: 2012-05-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP treatment	CPAP S8- Scape / Resmed	1000 patients with 3-years CPAP treatment after a PSG titration

Primary Outcome Measures

Name	Time	Method
costs of medical events post CPAP treatment	3 years	To evaluate the health satuts costs post-CPAP treatment.
Number of hospitalizations	3 years
Changes in medications	3 years

Secondary Outcome Measures

Name	Time	Method
Costs relative to CPAP treatment	3 years	To evaluate the influence of CPAP device on directs health costs

Trial Locations

Locations (1)

Associação Fundo de Incentivo à Pesquisa; 🇧🇷 Sao Paulo, Brazil