Obstructive Sleep Apnea SyndromePhase 4NCT01590420
Cost-utility Study of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome Patients
A Phase 4 study testing CPAP S8- Scape / Resmed in people with Obstructive Sleep Apnea Syndrome, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- CPAP S8- Scape / Resmed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders
- Aged 30 to 70 years old
- AHI > 30 events/hour
Who cannot join
- Patients residing in other cities and states other than São Paulo / SP / Brazil
- Patients with no fixed residence
- Previous CPAP contact
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Associação Fundo de Incentivo à Pesquisa
São Paulo, São Paulo, 04024-002
Camila F Rizzi, PhD, +55 (11) 85555049, camila.rizzi@unifesp.br
Camila F Rizzi, PhD
About this study
Official title: Cost-utility Study of CPAP Treatment in Obstructive Sleep Apnea Patients
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
Read the 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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- CPAP S8- Scape / Resmed
- Keywords
- OSA, Sleep, CPAP, Cost
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP S8- Scape / ResmedDevice
Also called S8 Escape, Resmed
The pressure for treatment is according to PSG titration
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | 1000 patients with 3-years CPAP treatment after a PSG titration Receives: Device: CPAP S8- Scape / Resmed |
What is being measured
The primary outcome is the main question the study is designed to answer.
costs of medical events post CPAP treatment
To evaluate the health satuts costs post-CPAP treatment.
Measured: 3 years
Number of hospitalizations
Measured: 3 years
Changes in medications
Measured: 3 years
Secondary outcomes (1)
Costs relative to CPAP treatment
To evaluate the influence of CPAP device on directs health costs
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startMar 2011
- Primary completionMar 2011
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camila Furtado Rizzi, Associação Fundo de Incentivo à Pesquisa
- Investigators
- Camila F Rizzi, PhD, Principal investigator, Federal University of São PauloDalva Poyares, PhD, Study chair, Federal University of São PauloSergio Tufik, PhD, Study director, Federal University of São PauloMarcos F Bosi, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590420
- Sponsor's protocol ID
- Cost-utility of OSAS
- Status last verified
- May 2012
- First submitted
- 1 May 2012
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility Study of CPAP Treatment in Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT01590420
- Acronym / sponsor ID
- Cost-utility of OSAS
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- OSA, Sleep, CPAP, Cost
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2014 (estimated)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: CPAP S8- Scape / Resmed1000 patients with 3-years CPAP treatment after a PSG titration |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both genders
- Aged 30 to 70 years old
- AHI > 30 events/hour
Key exclusion criteria (3 listed)
- Patients residing in other cities and states other than São Paulo / SP / Brazil
- Patients with no fixed residence
- Previous CPAP contact
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP S8- Scape / ResmedAlso: S8 Escape, ResmedThe pressure for treatment is according to PSG titration | Device | CPAP treatment |
Primary outcome
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
1 secondary outcome
Costs relative to CPAP treatment
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
Related trials for Obstructive Sleep Apnea Syndrome
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camila F Rizzi, PhD principal investigator
Federal University of São Paulo
Dalva Poyares, PhD study chair
Federal University of São Paulo
Sergio Tufik, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CPAP S8- Scape / Resmed in people with Obstructive Sleep Apnea Syndrome, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camila F Rizzi, PhD (+55 (11) 85555049, camila.rizzi@unifesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
costs of medical events post CPAP treatment (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2012.