Obstructive Sleep Apnea (OSA)
Conditions
Keywords
cost effectiveness analysis, primary care
Brief 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. 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_TESThome 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_TESTStandard protocol
The patients undergo the polysomnography via the health department's scheduling system
Sponsors
Escola Superior de Ciencias da Saude
University of Brasilia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incremental cost-effectiveness ratio (ICER) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction level | 6 months | Satisfaction level of each participant enrolled to do polysomnography evaluated by PCAtool in primary care or standard protocol |
| Apnea-hypopnea Index (AHI) | 6 months | 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 | Baseline to 6 months | the spent time for the patients to get the full diagnosis of obstructive sleep apnea |
Contacts
CONTACTVinicius Maldaner Vincius Maldaner, PhD
PRINCIPAL_INVESTIGATORVinicius Maldaner, PhD
University of Brasilia
Outcome results
None listed