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

May 2, 2012 updated by: Camila Furtado Rizzi, Associação Fundo de Incentivo à Pesquisa

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04024-002
        • Recruiting
        • Associação Fundo de Incentivo à Pesquisa
        • Contact:
        • Principal Investigator:
          • Camila F Rizzi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP treatment
1000 patients with 3-years CPAP treatment after a PSG titration
Device: CPAP S8- Scape / Resmed
The pressure for treatment is according to PSG titration
Other Names:
  • S8 Escape
  • Resmed

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associação Fundo de Incentivo à Pesquisa

Investigators

  • Principal Investigator: Camila F Rizzi, PhD, Federal University of São Paulo
  • Study Chair: Dalva Poyares, PhD, Federal University of São Paulo
  • Study Director: Sergio Tufik, PhD, Federal University of São Paulo
  • Study Chair: Marcos F Bosi, PhD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2011

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

May 1, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cost-utility of OSAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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