Biomarkers in Obstructive Sleep Apnea: Could Blood Tests Help Screen and Track OSA?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will enroll 120 adults to collect and analyze blood samples for inflammatory, metabolic, oxidative stress, and other candidate biomarkers related to obstructive sleep apnea (OSA). Participants with moderate-to-severe OSA will be randomized to immediate or delayed positive airway pressure therapy, while non-OSA controls will provide a baseline comparison. All participants will undergo standardized clinical evaluation and overnight polysomnography. Blood samples will be drawn at predefined visits to evaluate how biomarker levels change with treatment and to determine associations with OSA presence and severity. The goal is to identify biomarkers that improve screening, risk stratification, and monitoring of adults with OSA.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Otolaryngology, Medical University of Bialystok
  Bialystok, Podlaskie Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Ewa Olszewska, M.D., Prof.
• Email: ewa.olszewska@umb.edu.pl
• Phone: +48 85 831 82 69

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.