Cost-effectiveness Analysis of Home Polysomnography Made by Primary Care - (SONOPC Study)

N/ANot Yet RecruitingNCT07744880

Escola Superior de Ciencias da Saude60 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea (OSA)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: baseline from 6 months

Secondary Outcomes

Satisfaction level

Satisfaction level of each participant enrolled to do polysomnography evaluated by PCAtool in primary care or standard protocol

Time frame: 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).

Time frame: 6 months

Time to full diagnosis

the spent time for the patients to get the full diagnosis of obstructive sleep apnea

Time frame: Baseline to 6 months