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

Recruiting

• Conditions: Obstructive Sleep Apnea-Hypopnea Syndrome; Anxiety Disorders; Depressive Disorders

• Registration Number: NCT07120711
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-01
• Primary Completion: 2025-07-22
• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Children aged 2-18 years with obstructive snoring or sleep apnea features on initial ENT outpatient screening.

Adults (>18 years) with suspected OSAS in a sleep or respiratory clinic, presenting with chronic snoring, witnessed apneas, or daytime sleepiness, and without severe chronic heart, liver, kidney failure, psychiatric disorders, or pregnancy.

Signed written informed consent by the participant or their legal guardian. Not currently enrolled in any other registered clinical trial.

Exclusion Criteria

Presence of congenital craniofacial malformations. Severe heart, lung, liver, or kidney failure, or major neurological disease. Recent use of anti-inflammatory or other immunomodulatory medications. Current psychiatric disorder or pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expression levels of EGR2 and NLRP3 in PBMCs, saliva, and subcutaneous fat tissue	Jul 2025 - Sep 2026	Quantitative measurement of EGR2 and NLRP3 mRNA (by RNA-seq and RT-qPCR) and protein levels (by Western blot and ELISA) in peripheral blood mononuclear cells, saliva, and (when available) subcutaneous fat tissue collected at baseline. These molecular markers will be correlated with cognitive (MoCA) and mood (PHQ-9, GAD-7) scores

Secondary Outcome Measures

Name	Time	Method
Multi-omics association of molecular markers with clinical phenotypes	Jul 2025 - Sep 2026	Integration of transcriptomic (RNA-seq) and proteomic/metabolomic data from PBMC, saliva, and fat samples. Construction of weighted gene co-expression network analysis (WGCNA) modules and core protein-protein interaction (PPI) networks centered on EGR2/NLRP3, with annotation of inflammation and blood-brain barrier pathways; assessment of module eigengene correlations with AHI, minimum SpO₂, MoCA, PHQ-9, and GAD-7 scores.

Trial Locations

Locations (1)

Shanghai Xinhua hospital; 🇨🇳 Shanghai, China