Cost-utility Study of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome Patients
Cost-utility Study of CPAP Treatment in Obstructive Sleep Apnea Patients
1 other identifier
interventional
1,000
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMay 3, 2012
May 1, 2012
Same day
May 1, 2012
May 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
costs of medical events post CPAP treatment
To evaluate the health satuts costs post-CPAP treatment.
3 years
Number of hospitalizations
3 years
Changes in medications
3 years
Secondary Outcomes (1)
Costs relative to CPAP treatment
3 years
Study Arms (1)
CPAP treatment
EXPERIMENTAL1000 patients with 3-years CPAP treatment after a PSG titration
Interventions
The pressure for treatment is according to PSG titration
Eligibility Criteria
You may qualify if:
- Both genders
- Aged 30 to 70 years old
- AHI \> 30 events/hour
You may not qualify if:
- Patients residing in other cities and states other than São Paulo / SP / Brazil
- Patients with no fixed residence
- Previous CPAP contact
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Associação Fundo de Incentivo à Pesquisa
São Paulo, São Paulo, 04024-002, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 1, 2012
First Posted
May 3, 2012
Study Start
March 1, 2011
Primary Completion
March 1, 2011
Study Completion
March 1, 2014
Last Updated
May 3, 2012
Record last verified: 2012-05