Obstructive Sleep Apnea (OSA)SONOPCNCT07744880
Cost-effectiveness Analysis of Home Polysomnography Made by Primary Care - (SONOPC Study)
A study testing home polysomnography made by health professionals in primary care and Standard protocol in people with Obstructive Sleep Apnea (OSA), run by Escola Superior de Ciencias da Saude.
Trial summary
The goal of this randomized clinical trial is to assess the cost-effectiveness of a home polyssomnography made by primary care compared to standard protocol for diagnosing obstructive sleep apnea in both genders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- home polysomnography made by health professionals in primary care and Standard protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or older;
- present clinical suspicion of OSA, confirmed by screening using the STOP-BANG and Epworth Sleepiness Scale questionnaires;
- be receiving care at Basic Health Units (UBS), or be registered on the Central Regulation waiting list system for polysomnography (PSG);
Who cannot join
- use of home oxygen therapy;
- use of invasive or non-invasive mechanical ventilation;
- use of a tracheostomy;
- change of residence during the data collection period;
- known allergy to materials used in sleep monitoring equipment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cost-effectiveness Analysis of Home Polysomnography Made by Primary Care Compared to Standard Protocol in Health Public System in Brazil
The goal of this randomized clinical trial is to assess the cost-effectiveness of a home polyssomnography made by primary care compared to standard protocol for diagnosing obstructive sleep apnea in both genders. Researchers will compare if a polyssomnography made by primary care is more cost-effective than standard protocol to see if this strategy decrease the wait time to get this exam in public health system in Brazil .
Participants will undergo diagnostic screening using the STOP-BANG and Epworth questionnaires; following the identification of apnea risk, they will be randomized into two groups: one group will undergo the examination via the health department's scheduling system, while the other will do so through primary health care services at the unit closest to their residence.
Read the detailed description
Direct and indirect costs will be estimated for both arms, and the waiting time for patients to receive a diagnosis will be recorded, and the incremental cost-effectiveness ratio (ICER) will be calculated.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- home polysomnography made by health professionals in primary care, Standard protocol
- Keywords
- cost effectiveness analysis, primary care
- 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.
home polysomnography made by health professionals in primary careDiagnostic test
Also called primary care
Participants will undergo diagnostic screening using the STOP-BANG and Epworth questionnaires; following the identification of apnea risk will undergo a home polysomnography through primary health care services at the unit closest to their residence.
Standard protocolDiagnostic test
Also called regulatory system
The patients undergo the polysomnography via the health department's scheduling system
| Study group | Role | What they receive |
|---|---|---|
| Primary care | Experimental | The home polysomnography made by health professionals in primary care, and patients diagnosed with moderate to severe sleep apnea will be delivered to the unit closer to your house. Receives: Diagnostic Test: home polysomnography made by health professionals in primary care |
| Standard protocol | Active comparator | The polysomnography made by a reference center in a public hospital, when the patients have to sleep in a hospital ward after they are invited by the regulatory system fo the health system Receives: Diagnostic Test: Standard protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
incremental cost-effectiveness ratio (ICER)
The ICER will be calculated by: Costs of primary care - Cost of the standard intervention)/(Effect of primary care - Effect of the standard intervention, where the effect be assessed by the time to the patients get the full diagnosis.
Measured: baseline from 6 months
Secondary outcomes (3)
Satisfaction level
Satisfaction level of each participant enrolled to do polysomnography evaluated by PCAtool in primary care or standard protocol
Measured: 6 months
Apnea-hypopnea Index (AHI)
To assess the diagnostic validity of a primary care home polysomnography compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA), based on the results of the Apnea-hypopnea Index (AHI).
Measured: 6 months
Time to full diagnosis
the spent time for the patients to get the full diagnosis of obstructive sleep apnea
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Sep 2027 (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 (OSA)Studies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Ciencias da Saude
- Sponsor type
- University, hospital or other
- Collaborators
- University of Brasilia
- Responsible party
- Principal investigator, Vinicius Zacarias Maldaner da silva, Escola Superior de Ciencias da Saude
- Investigators
- Vinicius Maldaner, PhD, Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744880
- Sponsor's protocol ID
- 7.201.718
- Acronym
- SONOPC
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Analysis of Home Polysomnography Made by Primary Care Compared to Standard Protocol in Health Public System in Brazil
- ClinicalTrials.gov ID
- NCT07744880
- Acronym / sponsor ID
- SONOPC / 7.201.718
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- cost effectiveness analysis, primary care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Escola Superior de Ciencias da SaudeUniversity, hospital or other
- Collaborators
- University of Brasilia
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- 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 goal of this randomized clinical trial is to assess the cost-effectiveness of a home polyssomnography made by primary care compared to standard protocol for diagnosing obstructive sleep apnea in both genders. Researchers will compare if a polyssomnography made by primary care is more cost-effective than standard protocol to see if this strategy decrease the wait time to get this exam in public health system in Brazil .
Participants will undergo diagnostic screening using the STOP-BANG and Epworth questionnaires; following the identification of apnea risk, they will be randomized into two groups: one group will undergo the examination via the health department's scheduling system, while the other will do so through primary health care services at the unit closest to their residence.
Detailed description
Direct and indirect costs will be estimated for both arms, and the waiting time for patients to receive a diagnosis will be recorded, and the incremental cost-effectiveness ratio (ICER) will be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary care | Experimental | Diagnostic Test: home polysomnography made by health professionals in primary careThe home polysomnography made by health professionals in primary care, and patients diagnosed with moderate to severe sleep apnea will be delivered to the unit closer to your house. |
| Standard protocol | Active comparator | Diagnostic Test: Standard protocolThe polysomnography made by a reference center in a public hospital, when the patients have to sleep in a hospital ward after they are invited by the regulatory system fo the health system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years or older;
- present clinical suspicion of OSA, confirmed by screening using the STOP-BANG and Epworth Sleepiness Scale questionnaires;
- be receiving care at Basic Health Units (UBS), or be registered on the Central Regulation waiting list system for polysomnography (PSG);
Key exclusion criteria (5 listed)
- use of home oxygen therapy;
- use of invasive or non-invasive mechanical ventilation;
- use of a tracheostomy;
- change of residence during the data collection period;
- known allergy to materials used in sleep monitoring equipment.
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 |
|---|---|---|
| home polysomnography made by health professionals in primary careAlso: primary careParticipants will undergo diagnostic screening using the STOP-BANG and Epworth questionnaires; following the identification of apnea risk will undergo a home polysomnography through primary health care services at the unit closest to their residence. | Diagnostic test | Primary care |
| Standard protocolAlso: regulatory systemThe patients undergo the polysomnography via the health department's scheduling system | Diagnostic test | Standard protocol |
Primary outcome
incremental cost-effectiveness ratio (ICER)
Time frame: baseline from 6 months
The ICER will be calculated by: Costs of primary care - Cost of the standard intervention)/(Effect of primary care - Effect of the standard intervention, where the effect be assessed by the time to the patients get the full diagnosis.
3 secondary outcomes
Satisfaction level
Time frame: 6 months
Apnea-hypopnea Index (AHI)
Time frame: 6 months
Time to full diagnosis
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
Related trials for Obstructive Sleep Apnea (OSA)
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
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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
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Vinicius Maldaner, PhD principal investigator
University of Brasilia
Questions about this trial
What is this clinical trial studying?
A study testing home polysomnography made by health professionals in primary care and Standard protocol in people with Obstructive Sleep Apnea (OSA), run by Escola Superior de Ciencias da Saude.
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 5 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vinicius Maldaner Vincius Maldaner, PhD (+ 55 6131078443, vinicius.silva@unb.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incremental cost-effectiveness ratio (ICER) (time frame: baseline from 6 months). 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 4 Aug 2026.