Identification of Biomarkers of Obstructive Sleep Apnea.

NCT07723144 | Recruiting

• 1 other identifier: 2024/55/B/NZ7/00418
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Obstructive Sleep Apnea (OSA); Obstructive Sleep Apnea (OSAS); Obstructive Sleep Apnea (SAOS); Obstructive Sleep Apnea (Moderate to Severe)

Keywords

Obstructive sleep apnea; OSA; Positive airway pressure therapy; CPAP; Blood biomarkers; Polysomnography; Inflammation; Oxidative stress; Metabolomics; Precision medicine

Outcome Measures

Primary Outcomes (2)

• Difference in blood biomarker concentrations between participants with obstructive sleep apnea (OSA) and non-OSA controls at baseline

  Comparison of baseline serum and plasma concentrations of a predefined panel of circulating protein biomarkers (osteoprotegerin, cardiotrophin-1, chitinase-3-like protein 1/YKL-40, CRP, HbA1c, erythropoietin, thioredoxin, PD-L1) and a predefined multiplex panel of 48 cytokines, chemokines and growth factors, measured by ELISA and multiplex ELISA (Luminex), between adults with moderate-to-severe OSA (AHI \>=15) and non-OSA controls (AHI \<5) defined by polysomnography. Results will be reported in assay-appropriate units, including pg/mL, ng/mL, mg/L, or percentage, as applicable.

  At enrollment, prior to initiation of PAP therapy (baseline, Month 0).

• Change in blood biomarker concentrations in OSA participants after positive airway pressure (PAP) therapy.

  Change from baseline in serum and plasma concentrations of the predefined biomarker panel after positive airway pressure (PAP) therapy. In the Early Treatment Group change is assessed after 3 and 6 months of continuous PAP; in the Delay-TG after 3 months of PAP delivered between months 3 and 6. Aim: determine whether and to what degree biomarker values change in response to standard OSA treatment.

  Baseline, 3 months and 6 months.

Secondary Outcomes (5)

• Correlation between baseline blood biomarker concentrations and OSA severity (AHI)

  At enrollment, prior to initiation of PAP therapy (baseline, Month 0).

• Normalization of blood biomarker concentrations toward control values after PAP therapy in OSA participants.

  Control: baseline; Early-TG: Month 3 and Month 6; Delay-TG: Month 6.

• Effect of PAP treatment duration (3 vs 6 months) on blood biomarker concentrations

  3 months and 6 months

• Stability of blood biomarker concentrations in untreated OSA (3-month observation period).

  Baseline and 3 months (Delay-TG)

• Differences in serum and plasma metabolomic profiles between OSA and controls and in response to PAP therapy.

  Baseline, 3 months and 6 months

Other Outcomes (4)

• Differences in blood biomarker concentrations between moderate and severe OSA subgroups.

  Baseline, 3 months and 6 months

• Differences in blood biomarker concentrations between BMI categories (normal weight, overweight, obese).

  Baseline, 3 months and 6 months

• Differences in blood biomarker concentrations between female and male participants.

  Baseline, 3 months and 6 months

Study Arms (3)

Early Positive Airway Pressure (PAP) Therapy

EXPERIMENTAL

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) Therapy

EXPERIMENTAL

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 Group

NO INTERVENTION

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

Interventions

Positive Airway Pressure (PAP) Therapy DEVICE

Positive airway pressure (PAP) therapy will be administered according to current clinical practice guidelines for the treatment of obstructive sleep apnea. PAP settings will be individually titrated based on clinical assessment and sleep study findings to ensure effective treatment. Participants assigned to PAP therapy will use the device during sleep for the duration specified in the study protocol. Adherence to therapy will be monitored using device-recorded usage data.

Delayed Positive Airway Pressure (PAP) Therapy; Early Positive Airway Pressure (PAP) Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Bialystok: lead
• National Science Centre, Poland: collaborator

Study Sites (1)

Department of Otolaryngology, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-276, Poland

RECRUITING

Related Publications (10)

• Olszewska E, Pietrewicz TM, Swiderska M, Jamiolkowski J, Chabowski A. A Case-Control Study on the Changes in High-Sensitivity C-Reactive Protein and Tumor Necrosis Factor-Alpha Levels with Surgical Treatment of OSAS. Int J Mol Sci. 2022 Nov 15;23(22):14116. doi: 10.3390/ijms232214116.

  PMID: 36430593 BACKGROUND

• Mohit, Tomar MS, Araniti F, Pateriya A, Singh Kushwaha RA, Singh BP, Jurel SK, Singh RD, Shrivastava A, Chand P. Identification of metabolic fingerprints in severe obstructive sleep apnea using gas chromatography-Mass spectrometry. Front Mol Biosci. 2022 Nov 21;9:1026848. doi: 10.3389/fmolb.2022.1026848. eCollection 2022.

  PMID: 36504723 BACKGROUND

• Kheirandish-Gozal L, Gozal D. Obstructive Sleep Apnea and Inflammation: Proof of Concept Based on Two Illustrative Cytokines. Int J Mol Sci. 2019 Jan 22;20(3):459. doi: 10.3390/ijms20030459.

  PMID: 30678164 BACKGROUND

• Olszewska E, De Vito A, Heiser C, Vanderveken O, O'Connor-Reina C, Baptista P, Kotecha B, Vicini C. Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 3 Palatal Surgery, Outcomes and Follow-Up, Complications, and Post-Operative Management. J Clin Med. 2024 Sep 13;13(18):5438. doi: 10.3390/jcm13185438.

  PMID: 39336926 BACKGROUND

• Olszewska E, De Vito A, O'Connor-Reina C, Heiser C, Baptista P, Kotecha B, Vanderveken O, Vicini C. Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 2 Decision-Making in Surgical Management and Peri-Operative Considerations. J Clin Med. 2024 Apr 3;13(7):2083. doi: 10.3390/jcm13072083.

  PMID: 38610848 BACKGROUND

• Olszewska E, De Vito A, Baptista P, Heiser C, O'Connor-Reina C, Kotecha B, Vanderveken O, Vicini C. Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 1 Definitions and Diagnosis. J Clin Med. 2024 Jan 16;13(2):502. doi: 10.3390/jcm13020502.

  PMID: 38256636 BACKGROUND

• Olszewska E, Woodson BT. Palatal anatomy for sleep apnea surgery. Laryngoscope Investig Otolaryngol. 2019 Jan 10;4(1):181-187. doi: 10.1002/lio2.238. eCollection 2019 Feb.

  PMID: 30828637 BACKGROUND

• Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.

  PMID: 31300334 BACKGROUND

• Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.

  PMID: 23589584 BACKGROUND

• Olszewska, E., Chrapanie i Bezdechy. Diagnostyka i Leczenie [Snoring and Apnea. Diagnosis and Treatment] 2019, Warszawa: Medipage

  BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Inflammation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ewa Olszewska, M.D., Prof.

CONTACT

+48 85 831 82 69; ewa.olszewska@umb.edu.pl

Agnieszka Polecka, M.D.

CONTACT

+48 85 831 82 69; agnieszka.polecka@umb.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: December 19, 2025
• Primary Completion (Estimated): June 19, 2029
• Study Completion (Estimated): June 19, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-06

Locations

PL (1)