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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

CPAP S8- Scape / Resmed

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring OSA, Sleep, CPAP, Cost

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Associação Fundo de Incentivo à PesquisaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP treatment

Arm Description

1000 patients with 3-years CPAP treatment after a PSG titration

Outcomes

Primary Outcome Measures

costs of medical events post CPAP treatment

To evaluate the health satuts costs post-CPAP treatment.

Number of hospitalizations

Changes in medications

Secondary Outcome Measures

Costs relative to CPAP treatment

To evaluate the influence of CPAP device on directs health costs

Full Information

NCT ID

NCT01590420

First Posted

May 1, 2012

Last Updated

May 2, 2012

Sponsor

Associação Fundo de Incentivo à Pesquisa

1. Study Identification

Unique Protocol Identification Number

NCT01590420

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Unknown status

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Associação Fundo de Incentivo à Pesquisa

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea Syndrome

Keywords

OSA, Sleep, CPAP, Cost

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CPAP treatment

Arm Type

Experimental

Arm Description

1000 patients with 3-years CPAP treatment after a PSG titration

Intervention Type

Device

Intervention Name(s)

CPAP S8- Scape / Resmed

Other Intervention Name(s)

S8 Escape, Resmed

Intervention Description

The pressure for treatment is according to PSG titration

Primary Outcome Measure Information:

Title

costs of medical events post CPAP treatment

Description

To evaluate the health satuts costs post-CPAP treatment.

Time Frame

3 years

Title

Number of hospitalizations

Time Frame

3 years

Title

Changes in medications

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Costs relative to CPAP treatment

Description

To evaluate the influence of CPAP device on directs health costs

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Camila F Rizzi, PhD

Phone

+55 (11) 85555049

camila.rizzi@unifesp.br

First Name & Middle Initial & Last Name or Official Title & Degree

Dalva Poyares, PhD

Phone

+55 (11) 85937418

poyares@unifesp.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Camila F Rizzi, PhD

Organizational Affiliation

Federal University of São Paulo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dalva Poyares, PhD

Organizational Affiliation

Federal University of São Paulo

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Sergio Tufik, PhD

Organizational Affiliation

Federal University of São Paulo

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Marcos F Bosi, PhD

Organizational Affiliation

Federal University of São Paulo

Official's Role

Study Chair

Facility Information:

Facility Name

Associação Fundo de Incentivo à Pesquisa

City

Sao Paulo

ZIP/Postal Code

04024-002

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Camila F Rizzi, PhD

Phone

+55 (11) 85555049

camila.rizzi@unifesp.br

First Name & Middle Initial & Last Name & Degree

Camila F Rizzi, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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