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.
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);
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;
Parallel
home polysomnography made by health professionals in primary care
Diagnostic testParticipants 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 protocol
Diagnostic testThe patients undergo the polysomnography via the health department's scheduling system
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.
Satisfaction level
Satisfaction level of each participant enrolled to do polysomnography evaluated by PCAtool in primary care or standard protocol
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).
Time to full diagnosis
the spent time for the patients to get the full diagnosis of obstructive sleep apnea
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Escola Superior de Ciencias da Saude
Lead sponsor
University of Brasilia
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
