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

NCT ID: NCT01590420

Last Updated: 2012-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-03-31

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.

Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP treatment

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

Group Type EXPERIMENTAL

CPAP S8- Scape / Resmed

Intervention Type DEVICE

The pressure for treatment is according to PSG titration

Interventions

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CPAP S8- Scape / Resmed

The pressure for treatment is according to PSG titration

Intervention Type DEVICE

Other Intervention Names

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S8 Escape Resmed

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role lead

Responsible Party

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Camila Furtado Rizzi

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Camila F Rizzi, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Dalva Poyares, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Sergio Tufik, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Marcos F Bosi, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Associação Fundo de Incentivo à Pesquisa

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Camila F Rizzi, PhD

Role: CONTACT

+55 (11) 85555049

Dalva Poyares, PhD

Role: CONTACT

+55 (11) 85937418

Facility Contacts

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Camila F Rizzi, PhD

Role: primary

+55 (11) 85555049

Other Identifiers

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Cost-utility of OSAS

Identifier Type: -

Identifier Source: org_study_id

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