Identification de Biomarqueurs pour l'Amélioration du Dépistage et de la Surveillance de l'Apnée Obstructive du Sommeil
Cette étude vise à identifier des biomarqueurs pour améliorer le dépistage et la surveillance de l'apnée obstructive du sommeil (AOS) en comparant les concentrations de biomarqueurs sanguins entre les participants atteints d'AOS et les témoins non-AOS au début, et en observant les changements de ces concentrations chez les participants AOS après une thérapie par pression positive des voies aériennes (PAP).
Positive Airway Pressure (PAP) Therapy
+ Positive Airway Pressure (PAP) Therapy
Apnée+9
+ Maladies du système nerveux
+ Processus pathologiques
Étude diagnostique
Résumé
Date de début de l'étude : 19 décembre 2025
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.120 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Diagnostic
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.3 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalGroupe III
Pas d'interventionObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Department of Otolaryngology, Medical University of Bialystok
Bialystok, PolandOuvrir Department of Otolaryngology, Medical University of Bialystok dans Google Maps