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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Associação Fundo de Incentivo à Pesquisa.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Camila Furtado Rizzi, Associação Fundo de Incentivo à Pesquisa Identifier:
First received: May 1, 2012
Last updated: May 2, 2012
Last verified: May 2012
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:

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.


Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01590420

Associação Fundo de Incentivo à Pesquisa
Sao Paulo, Brazil, 04024-002
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
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

Responsible Party: Camila Furtado Rizzi, PhD, Associação Fundo de Incentivo à Pesquisa 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:

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on December 09, 2016