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

This study is currently recruiting participants.
Verified May 2012 by Associação Fundo de Incentivo à Pesquisa
Sponsor:
Information provided by (Responsible Party):
Camila Furtado Rizzi, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier:
NCT01590420
First received: May 1, 2012
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Obstructive Sleep Apnea Syndrome
 Device: CPAP S8- Scape / Resmed
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cost-utility Study of CPAP Treatment in Obstructive Sleep Apnea Patients

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Associação Fundo de Incentivo à Pesquisa:

Primary Outcome Measures:
  • costs of medical events post CPAP treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To evaluate the health satuts costs post-CPAP treatment.

  • Number of hospitalizations [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Changes in medications [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Costs relative to CPAP treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To evaluate the influence of CPAP device on directs health costs


Estimated Enrollment: 1000
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590420

Contacts
Contact: Camila F Rizzi, PhD +55 (11) 85555049 camila.rizzi@unifesp.br
Contact: Dalva Poyares, PhD +55 (11) 85937418 poyares@unifesp.br

Locations
Brazil
Associação Fundo de Incentivo à Pesquisa Recruiting
Sao Paulo, Brazil, 04024-002
Contact: Camila F Rizzi, PhD     +55 (11) 85555049     camila.rizzi@unifesp.br    
Principal Investigator: Camila F Rizzi, PhD            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Camila Furtado Rizzi, PhD, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier: NCT01590420     History of Changes
Other Study ID Numbers: Cost-utility of OSAS
Study First Received: May 1, 2012
Last Updated: May 2, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Associação Fundo de Incentivo à Pesquisa:
OSA
Sleep
CPAP
Cost

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013