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

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ClinicalTrials.gov Identifier: NCT01590420
Recruitment Status : Unknown
Verified May 2012 by Camila Furtado Rizzi, Associação Fundo de Incentivo à Pesquisa.
Recruitment status was:  Recruiting
First Posted : May 3, 2012
Last Update Posted : May 3, 2012
Sponsor:
Information provided by (Responsible Party):
Camila Furtado Rizzi, Associação Fundo de Incentivo à Pesquisa

Tracking Information
First Submitted Date  ICMJE May 1, 2012
First Posted Date  ICMJE May 3, 2012
Last Update Posted Date May 3, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • costs of medical events post CPAP treatment [ Time Frame: 3 years ]
    To evaluate the health satuts costs post-CPAP treatment.
  • Number of hospitalizations [ Time Frame: 3 years ]
  • Changes in medications [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
Costs relative to CPAP treatment [ Time Frame: 3 years ]
To evaluate the influence of CPAP device on directs health costs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cost-utility Study of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome Patients
Official Title  ICMJE Cost-utility Study of CPAP Treatment in Obstructive Sleep Apnea Patients
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea Syndrome
Intervention  ICMJE Device: CPAP S8- Scape / Resmed
The pressure for treatment is according to PSG titration
Other Names:
  • S8 Escape
  • Resmed
Study Arms  ICMJE Experimental: CPAP treatment
1000 patients with 3-years CPAP treatment after a PSG titration
Intervention: Device: CPAP S8- Scape / Resmed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 2, 2012)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01590420
Other Study ID Numbers  ICMJE Cost-utility of OSAS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Camila Furtado Rizzi, Associação Fundo de Incentivo à Pesquisa
Study Sponsor  ICMJE Associação Fundo de Incentivo à Pesquisa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Associação Fundo de Incentivo à Pesquisa
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP