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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cost-utility Study of CPAP Treatment in Obstructive Sleep Apnea Patients

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: CPAP S8- Scape / Resmed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP treatment<br>1000 patients with 3-years CPAP treatment after a PSG titration | Device: CPAP S8- Scape / Resmed<br>* The pressure for treatment is according to PSG titration<br>* Other names: Resmed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| costs of medical events post CPAP treatment | To evaluate the health satuts costs post-CPAP treatment. | 3 years | 
| Number of hospitalizations |  | 3 years | 
| Changes in medications |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs relative to CPAP treatment | To evaluate the influence of CPAP device on directs health costs | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cost, OSA, Sleep, CPAP