Cost-effectiveness Analysis of Home Polysomnography Made by Primary Care - (SONOPC Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: home polysomnography made by health professionals in primary care, Standard protocol.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea (OSA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cost-effectiveness Analysis of Home Polysomnography Made by Primary Care Compared to Standard Protocol in Health Public System in Brazil
Overview
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.
Interventions
- Diagnostic test home polysomnography made by health professionals in 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. - Diagnostic test Standard protocol
The patients undergo the polysomnography via the health department's scheduling system
Primary outcome measures
- incremental cost-effectiveness ratio (ICER) [Time frame: baseline from 6 months]
Secondary outcome measures (3)
- Satisfaction level [Time frame: 6 months]
- Apnea-hypopnea Index (AHI) [Time frame: 6 months]
- Time to full diagnosis [Time frame: Baseline to 6 months]
Eligibility criteria
Inclusion criteria
- 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);
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07744880 · 7.201.718