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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Diagnostic test: home polysomnography made by health professionals in primary care; Diagnostic test: Standard protocol

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vinicius Maldaner Vincius Maldaner, PhD; Phone Number: + 55 6131078443; Email: vinicius.silva@unb.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary care; 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.	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.; Other Names: primary care
Active Comparator: Standard protocol; 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	Diagnostic test: Standard protocol; The patients undergo the polysomnography via the health department's scheduling system; Other Names: regulatory system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline from 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction level	Satisfaction level of each participant enrolled to do polysomnography evaluated by PCAtool in primary care or standard protocol	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).	6 months
Time to full diagnosis	the spent time for the patients to get the full diagnosis of obstructive sleep apnea	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Escola Superior de Ciencias da Saude
• Collaborators: University of Brasilia
• Investigators: Principal Investigator: Vinicius Maldaner, PhD, University of Brasilia

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: July 24, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: primary care; cost effectiveness analysis
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 7.201.718

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No