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NCT Number: NCT07744880

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

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.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: primary care

Standard protocol

Diagnostic Test

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

Other names: regulatory system

Primary outcomes

  1. incremental cost-effectiveness ratio (ICER)

    Time frame: 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 outcomes

  1. Satisfaction level

    Time frame: 6 months

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

  2. Apnea-hypopnea Index (AHI)

    Time frame: 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).

  3. Time to full diagnosis

    Time frame: Baseline to 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Vinicius Maldaner Vincius Maldaner, PhD

CONTACT

[email protected]

+ 55 6131078443

Sponsors and collaborators

Lead sponsor

Escola Superior de Ciencias da Saude

Other

Collaborators

  • University of Brasilia

Registry information

Official study title

Cost-effectiveness Analysis of Home Polysomnography Made by Primary Care Compared to Standard Protocol in Health Public System in Brazil

Acronym: SONOPC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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