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NCT07723144

Overview

NCT ID: NCT07723144
Lead Sponsor: Medical University of BialystokOTHER
Official Title: Identification of Biomarkers to Understand the Pathogenesis of Obstructive Sleep Apnea.
Brief Summary: 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.

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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Dec 19, 2025Actual
Primary Completion Date: Jun 19, 2029Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

Mild obstructive sleep apnea (AHI 5 to <15 events/hour).

Central sleep apnea.

Previous treatment for obstructive sleep apnea within the previous 3 months.

Body mass index (BMI) ≥40 kg/m².

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.

Respiratory infection within 4 weeks before enrollment.

Major surgery or significant injury within the previous 3 months.

Chronic rhinosinusitis.

Current treatment with systemic corticosteroids, immunosuppressive drugs, cytotoxic drugs, chronic anti-inflammatory medications, or other medications that may influence inflammatory biomarkers.

Pregnancy or any condition that, in the opinion of the investigators, would make participation unsafe or interfere with interpretation of the study results.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 120Estimated
Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Ewa Olszewska, M.D., Prof.Contact
ewa.olszewska@umb.edu.pl+48 85 831 82 69

Similar Studies

Participant Group/Arms

Early Positive Airway Pressure (PAP) TherapyExperimental

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.

Device: Positive Airway Pressure (PAP) Therapy

Delayed Positive Airway Pressure (PAP) TherapyExperimental

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.

Device: Positive Airway Pressure (PAP) Therapy

Control GroupNo Intervention

Participants without obstructive sleep apnea undergo baseline clinical evaluation, overnight polysomnography, and blood sampling. No PAP therapy or study intervention is administered.