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

NCT07744880 | Not Yet Recruiting

• 1 other identifier: 7.201.718
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

cost effectiveness analysis; primary care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Satisfaction level

  6 months

• Apnea-hypopnea Index (AHI)

  6 months

• Time to full diagnosis

  Baseline to 6 months

Study Arms (2)

Primary care

EXPERIMENTAL

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

Standard protocol

ACTIVE COMPARATOR

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

Interventions

home polysomnography made by health professionals in primary care DIAGNOSTIC_TEST

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.

Also known as: primary care

Primary care

Standard protocol DIAGNOSTIC_TEST

The patients undergo the polysomnography via the health department's scheduling system

Also known as: regulatory system

Standard protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Ciencias da Saude: lead
• University of Brasilia: collaborator

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Vinicius Maldaner, PhD

  University of Brasilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinicius Maldaner Vincius Maldaner, PhD

CONTACT

+ 55 6131078443; vinicius.silva@unb.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07