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

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

Cost-utility Study of CPAP Treatment in Obstructive Sleep Apnea Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01590420
• Other study ID #: Cost-utility of OSAS
• Status: Recruiting
• Phase: Phase 4
• First received: May 1, 2012
• Last updated: May 2, 2012
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: May 2012
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: Camila F Rizzi, PhD
• Phone: +55 (11) 85555049
• Email: camila.rizzi[@]unifesp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 2014
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP S8- Scape / Resmed
The pressure for treatment is according to PSG titration

Locations

Country	Name	City	State
Brazil	Associação Fundo de Incentivo à Pesquisa	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	costs of medical events post CPAP treatment	To evaluate the health satuts costs post-CPAP treatment.	3 years	No
Primary	Number of hospitalizations		3 years	No
Primary	Changes in medications		3 years	No
Secondary	Costs relative to CPAP treatment	To evaluate the influence of CPAP device on directs health costs	3 years	No