Clinical Trial

EGR2 and NLRP3 Pathways in Obstructive Sleep Apnea-Related Cognitive and Mood Disorders

Recruiting
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Summary
Obstructive sleep apnea-hypopnea syndrome (OSAS) is a common disorder in which repeated airway blockages during sleep lead to low oxygen levels, inflammation, and disrupted sleep. Many OSAS patients-both children and adults-experience problems with memory, attention, and mood, such as anxiety or depression. However, the exact molecular drivers of these brain changes are not fully understood. This observational study will enroll: Children (ages 2-18) and adults (\>18 years) with OSAS, as well as age- and sex-matched healthy volunteers. Clinical assessments: Children will undergo routine ENT examinations (including nasal endoscopy and X-rays); adults will have an overnight sleep study (polysomnography). All participants will complete questionnaires on sleepiness (e.g., ESS), mood (PHQ-9, GAD-7), and cognitive screening (MoCA for adults, age-appropriate scales for children). Sample collection: A small blood draw (3 mL) and, when applicable (e.g., adults undergoing surgery), a tiny subcutaneous fat biopsy. Saliva samples will also be collected. Laboratory tests: Measure expression levels of two key inflammatory pathway genes-EGR2 and NLRP3-in blood cells, saliva, and fat tissue using RNA sequencing, RT-qPCR, and Western Blot. Correlate these molecular markers with sleep parameters (AHI, oximetry), cognitive scores, and mood scores. Data analysis: Develop and validate machine-learning models that integrate data from multiple tissues to predict who is at highest risk for cognitive or mood disturbances.
Trial Details
NCT Number NCT07120711
Lead Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions Obstructive Sleep Apnea-Hypopnea Syndrome, Anxiety Disorders, Depressive Disorders
Enrollment 1,000 participants
Start Date 2025-07-01
Primary Completion 2025-07-22 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-13