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Identification of Biomarkers of Obstructive Sleep Apnea.

20 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

120

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Polônia
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polônia, 15-276
        • Recrutamento
        • Department of Otolaryngology, Medical University of Bialystok
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Dispositivo: 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.
Experimental: 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.
Dispositivo: 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.
Sem intervenção: Control Group
Participants without obstructive sleep apnea undergo baseline clinical evaluation, overnight polysomnography, and blood sampling. No PAP therapy or study intervention is administered.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Difference in blood biomarker concentrations between participants with obstructive sleep apnea (OSA) and non-OSA controls at baseline
Prazo: 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.
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Correlation between baseline blood biomarker concentrations and OSA severity (AHI)
Prazo: 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.
Prazo: 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
Prazo: 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).
Prazo: 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.
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Differences in blood biomarker concentrations between moderate and severe OSA subgroups.
Prazo: 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).
Prazo: 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.
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Medical University of Bialystok

Colaboradores

National Science Centre, Poland

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

19 de dezembro de 2025

Conclusão Primária (Estimado)

19 de junho de 2029

Conclusão do estudo (Estimado)

19 de junho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

20 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de julho de 2026

Primeira postagem (Real)

23 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de julho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2024/55/B/NZ7/00418

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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