Taking peopleNo phase

Identification of Biomarkers of Obstructive Sleep Apnea.

Key facts

Who runs it: Medical University of Bialystok
Where: Poland1 site in 1 countryChoose a country to see its sites
Trial code: NCT07723144
Status: Recruiting
People taking part: 120 people, planned
Started: 19 Dec 2025
Expected to end: 19 Jun 2029
Type of study: Interventional, 3 groupsOne group gets no study treatment, for comparison.
Treatments tested: Positive Airway Pressure (PAP) Therapy
Record updated: 23 July 2026

Who can take part

Age: 18 years to 65 years
Sex: Women and men
Healthy volunteers: Can take part

The registry criteria, word for word

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Who can take part

Participants with obstructive sleep apnea (OSA):; Age 18 to 65 years; Moderate or severe obstructive sleep apnea confirmed by overnight polysomnography (apnea-hypopnea index [AHI] ≥15 events/hour); Willing and able to provide written informed consent; Willing to undergo repeated blood sampling and study assessments; Willing to use positive airway pressure (PAP) therapy and accept random assignment to immediate or delayed treatment
Control participants:; Age 18 to 65 years; No obstructive sleep apnea (AHI <5 events/hour on overnight polysomnography); Willing and able to provide written informed consent; Willing to undergo study assessments and blood sampling

Who cannot take part

Previous treatment for obstructive sleep apnea within the previous 3 months
Respiratory infection within 4 weeks before enrollment
Major surgery or significant injury within the previous 3 months
Current treatment with systemic corticosteroids, immunosuppressive drugs, cytotoxic drugs, chronic anti-inflammatory medications, or other medications that may influence inflammatory biomarkers
Severe cardiovascular disease
Severe kidney disease or impaired renal function
Significant liver disease
Chronic inflammatory, autoimmune, or rheumatic disease
Active cancer or other condition associated with systemic inflammation
Chronic respiratory diseases, including asthma or chronic obstructive pulmonary disease
Pregnancy or any condition that, in the opinion of the investigators, would make participation unsafe or interfere with interpretation of the study results
Mild obstructive sleep apnea (AHI 5 to <15 events/hour)
Central sleep apnea
Body mass index (BMI) ≥40 kg/m²
Chronic rhinosinusitis

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 65 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Obstructive sleep apnea (OSA) is a common sleep disorder associated with intermittent hypoxia, systemic inflammation, oxidative stress, and an increased risk of cardiovascular and metabolic diseases. Current diagnostic methods are effective but have limited availability and do not adequately predict disease burden or treatment response.

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The purpose of this study is to identify and validate blood biomarkers that may improve the screening, diagnosis, risk stratification, and monitoring of adults with OSA. A total of 120 participants will undergo clinical evaluation and overnight polysomnography. Participants with moderate-to-severe OSA will be randomly assigned to either immediate or delayed positive airway pressure (PAP) therapy, while participants without OSA will serve as controls. Blood samples will be collected at predefined time points and analyzed for inflammatory, metabolic, oxidative stress, and other candidate biomarkers.

The study aims to determine which biomarkers are associated with OSA severity and how they change in response to PAP therapy. The results may contribute to the development of more accessible and personalized diagnostic and monitoring strategies for patients with OSA.

The 3 groups in the trial

Early Positive Airway Pressure (PAP) TherapyTreatment being tested
Participants with moderate-to-severe obstructive sleep apnea receive positive airway pressure (PAP) therapy immediately after randomization and continue treatment for 6 months. Clinical assessments and blood samples are obtained at baseline, 3 months, and 6 months.
Treatment: Positive Airway Pressure (PAP) Therapy
Delayed Positive Airway Pressure (PAP) TherapyTreatment being tested
Participants with moderate-to-severe obstructive sleep apnea do not receive PAP therapy during the first 3 months after randomization. PAP therapy is initiated after the 3-month evaluation and continued for the following 3 months. Clinical assessments and blood samples are obtained at baseline, 3 months, and 6 months.
Treatment: Positive Airway Pressure (PAP) Therapy
Control GroupNo study treatment, for comparison
Participants without obstructive sleep apnea undergo baseline clinical evaluation, overnight polysomnography, and blood sampling. No PAP therapy or study intervention is administered.