Biomarker Identification for Improved Obstructive Sleep Apnea Screening and Monitoring
This study aims to identify biomarkers for improved obstructive sleep apnea (OSA) screening and monitoring by comparing blood biomarker concentrations between participants with OSA and non-OSA controls at baseline, and observing changes in these concentrations in OSA participants after positive airway pressure (PAP) therapy.
Positive Airway Pressure (PAP) Therapy
+ Positive Airway Pressure (PAP) Therapy
Apnea+9
+ Nervous System Diseases
+ Pathologic Processes
Diagnostic Study
Summary
Study start date: December 19, 2025
Actual date on which the first participant was enrolled.Obstructive sleep apnea (OSA) is a highly prevalent disorder characterized by recurrent upper airway obstruction during sleep, resulting in intermittent hypoxia, sleep fragmentation, oxidative stress, systemic inflammation, endothelial dysfunction, and metabolic disturbances. Untreated OSA is associated with an increased risk of cardiovascular disease, diabetes mellitus, stroke, impaired quality of life, and all-cause mortality. Despite the availability of polysomnography as the reference diagnostic method, current diagnostic approaches have limited accessibility and do not adequately reflect disease burden or predict treatment response. The primary objective of this study is to identify and validate blood biomarkers associated with the presence, severity, and treatment response of OSA. The investigators hypothesize that selected circulating proteins, inflammatory mediators, oxidative stress markers, and metabolic profiles can improve the screening, diagnosis, risk stratification, and monitoring of patients with OSA. A total of 120 adults will undergo standardized clinical evaluation and overnight polysomnography. Participants diagnosed with moderate-to-severe OSA will be randomly assigned to either immediate or delayed initiation of positive airway pressure (PAP) therapy, whereas participants without OSA will serve as the control group. Blood samples will be collected at predefined study visits to evaluate changes in candidate biomarkers before and during treatment. The study will investigate a broad panel of biomarkers representing inflammatory pathways, endothelial dysfunction, oxidative stress, and metabolomic alterations using validated laboratory techniques, including multiplex immunoassays, enzyme-linked immunosorbent assays (ELISA), and metabolomic analyses. Changes in biomarker profiles will be evaluated in relation to OSA severity and response to PAP therapy. The results of this study are expected to improve the understanding of the biological mechanisms underlying OSA and facilitate the development of novel biomarker-based approaches for screening, diagnosis, disease monitoring, and personalized management of patients with obstructive sleep apnea.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. 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. 2. 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
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Otolaryngology, Medical University of Bialystok
Bialystok, PolandOpen Department of Otolaryngology, Medical University of Bialystok in Google Maps