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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Depressive Disorders
Obstructive Sleep Apnea-Hypopnea Syndrome
Anxiety Disorders

Treatments

Procedure: fatty tissue
Procedure: EGR2/NLRP3 pathway activity

Study type

Observational

Funder types

Other

Identifiers

NCT07120711
XHEC-C-2025-163-1

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

5+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

1,000 participants in 4 patient groups

OSAS_chlidren
Treatment:
Procedure: EGR2/NLRP3 pathway activity
OSAS_adult
Treatment:
Procedure: EGR2/NLRP3 pathway activity
Procedure: fatty tissue
non_OSAS_chlidren
Treatment:
Procedure: EGR2/NLRP3 pathway activity
non_OSAS_adult
Treatment:
Procedure: EGR2/NLRP3 pathway activity
Procedure: fatty tissue

Trial contacts and locations

1

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Central trial contact

Jiang, PHD,MD

Data sourced from clinicaltrials.gov

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