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Identification of Biomarkers of Obstructive Sleep Apnea.

20 lipca 2026 zaktualizowane przez: Medical University of Bialystok

Identification of Biomarkers to Understand the Pathogenesis of Obstructive Sleep Apnea.

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

120

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Polska
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polska, 15-276
        • Rekrutacyjny
        • Department of Otolaryngology, Medical University of Bialystok
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Diagnostyczny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Early Positive Airway Pressure (PAP) Therapy
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.
Urządzenie: Positive Airway Pressure (PAP) Therapy
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.
Eksperymentalny: Delayed Positive Airway Pressure (PAP) Therapy
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.
Urządzenie: Positive Airway Pressure (PAP) Therapy
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.
Brak interwencji: Control Group
Participants without obstructive sleep apnea undergo baseline clinical evaluation, overnight polysomnography, and blood sampling. No PAP therapy or study intervention is administered.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Difference in blood biomarker concentrations between participants with obstructive sleep apnea (OSA) and non-OSA controls at baseline
Ramy czasowe: At enrollment, prior to initiation of PAP therapy (baseline, Month 0).
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.
Ramy czasowe: Baseline, 3 months and 6 months.
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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Correlation between baseline blood biomarker concentrations and OSA severity (AHI)
Ramy czasowe: At enrollment, prior to initiation of PAP therapy (baseline, Month 0).
Correlation between baseline concentrations of the studied blood biomarkers and OSA severity expressed by the apnea-hypopnea index (AHI), as well as mean and lowest nocturnal oxygen saturation, in OSA participants. Goal: evaluate suitability of biomarkers for grading OSA severity.
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.
Ramy czasowe: Control: baseline; Early-TG: Month 3 and Month 6; Delay-TG: Month 6.
Comparison of post-PAP-treatment biomarker concentrations in OSA participants (Early-TG and Delay-TG) with the enrollment values of the non-OSA control group, to assess whether treatment shifts biomarker values toward those of healthy controls. Goal: identify biomarkers specific to OSA-related hypoxia that approach the concentrations observed in participants without OSA.
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
Ramy czasowe: 3 months and 6 months
Assessment of the impact of PAP treatment duration on biomarker values: (a) comparison of post-treatment values between the Early Treatment Group (6 months of PAP) and the Delay Treatment Group (3 months of PAP); (b) within Early-TG, comparison of values after 3 versus 6 months to evaluate whether changes become more robust with continued treatment. Goal: determine whether longer therapy produces greater biomarker change.
3 months and 6 months
Stability of blood biomarker concentrations in untreated OSA (3-month observation period).
Ramy czasowe: Baseline and 3 months (Delay-TG)
Comparison of biomarker concentrations in the Delay-TG between baseline and after the 3-month observation period without any treatment, to verify that biomarker values do not change spontaneously in the absence of PAP therapy. Serves as the internal untreated reference for the treatment effect.
Baseline and 3 months (Delay-TG)
Differences in serum and plasma metabolomic profiles between OSA and controls and in response to PAP therapy.
Ramy czasowe: Baseline, 3 months and 6 months
Targeted and untargeted metabolomic profiling (GC-MS and LC-QTOF-MS; amino acids, carbohydrates, fatty acids, and specific lipids including phosphatidylcholines, ceramides, triglycerides and lysophosphatidylcholines) compared between OSA participants and controls at baseline, and before versus after PAP therapy in OSA participants. Goal: identify known and novel metabolite biomarkers of OSA.
Baseline, 3 months and 6 months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Differences in blood biomarker concentrations between moderate and severe OSA subgroups.
Ramy czasowe: Baseline, 3 months and 6 months
Comparison of biomarker concentrations between participants with moderate OSA (15<=AHI<30) and severe OSA (AHI>=30) at baseline and in response to PAP therapy.
Baseline, 3 months and 6 months
Differences in blood biomarker concentrations between BMI categories (normal weight, overweight, obese).
Ramy czasowe: Baseline, 3 months and 6 months
Comparison of biomarker concentrations between body-mass-index categories (normal <25, overweight 25-<30, obese >=30) at baseline and in response to PAP therapy, to assess whether biomarker profile and treatment response differ by weight category.
Baseline, 3 months and 6 months
Differences in blood biomarker concentrations between female and male participants.
Ramy czasowe: Baseline, 3 months and 6 months
Comparison of biomarker concentrations between female and male participants at baseline and in response to PAP therapy, to assess sex-related differences in biomarker profile and treatment response.
Baseline, 3 months and 6 months
Concentrations of oxidative stress biomarkers in OSA participants and controls
Ramy czasowe: Baseline, 3 months and 6 months
Assessment of protein, lipid and DNA oxidation products: advanced oxidation protein products (AOPP, colorimetric method), ischemia-modified albumin, advanced glycation end products, 3-nitrotyrosine, 4-hydroxynonenal, 8-isoprostanes and 8-hydroxy-2-deoxyguanosine (ELISA), compared between OSA and controls at baseline and before versus after PAP therapy.
Baseline, 3 months and 6 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Medical University of Bialystok

Współpracownicy

National Science Centre, Poland

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

19 grudnia 2025

Zakończenie podstawowe (Szacowany)

19 czerwca 2029

Ukończenie studiów (Szacowany)

19 czerwca 2029

Daty rejestracji na studia

Pierwszy przesłany

20 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 lipca 2026

Pierwszy wysłany (Rzeczywisty)

23 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 lipca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2024/55/B/NZ7/00418

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

The individual participant data sharing plan has not yet been determined. A final decision will be made after study completion in accordance with institutional policies, ethical approvals, and applicable regulations.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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