Obstructive Sleep Apnea Syndrome Clinical Trial
Official title:
Cost-utility Study of CPAP Treatment in Obstructive Sleep Apnea Patients
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
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | March 2014 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 70 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Associação Fundo de Incentivo à Pesquisa | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Associação Fundo de Incentivo à Pesquisa |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | costs of medical events post CPAP treatment | To evaluate the health satuts costs post-CPAP treatment. | 3 years | No |
Primary | Number of hospitalizations | 3 years | No | |
Primary | Changes in medications | 3 years | No | |
Secondary | Costs relative to CPAP treatment | To evaluate the influence of CPAP device on directs health costs | 3 years | No |
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