EGR2 and NLRP3 pathways in sleep apnea-related thinking and mood problems

Regulatory Mechanisms of EGR2 and NLRP3 Inflammatory Pathways in Cognitive Impairment and Depressive-Anxiety-Like Behaviors Associated With Obstructive Sleep Apnea-Hypopnea Syndrome

This study will test whether activity in the EGR2 and NLRP3 inflammation pathways is linked to thinking, memory, and mood problems in children and adults with obstructive sleep apnea compared with healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 5 Years and up
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07120711 on ClinicalTrials.gov

What this trial studies

This observational study will enroll children (ages 2–18) and adults (>18) with obstructive sleep apnea-hypopnea syndrome (OSAS) alongside age- and sex-matched healthy volunteers. Children will undergo ENT examinations including nasal endoscopy and X-rays, while adults will receive overnight polysomnography; all participants will complete standardized sleepiness, mood, and cognitive questionnaires. Small blood draws will be collected from all participants and tiny adipose tissue samples obtained when available (for example during surgery) to measure EGR2 and NLRP3 pathway activity and inflammatory markers. Molecular data will be correlated with cognitive screening and mood scores to explore mechanisms linking intermittent hypoxia and inflammation to neurobehavioral symptoms in OSAS.

Who should consider this trial

Good fit: Children aged 2–18 with obstructive snoring or sleep apnea features on ENT screening and adults >18 with suspected OSAS (chronic snoring, witnessed apneas, or daytime sleepiness) who are not pregnant and do not have severe organ failure or major neurological disease are ideal candidates.

Not a fit: Patients with congenital craniofacial malformations, severe heart, lung, liver, or kidney failure, major neurological disease, current psychiatric disorders, recent use of immunomodulatory drugs, pregnancy, or participation in another clinical trial are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify molecular markers that explain cognitive and mood problems in OSAS and suggest new targets for prevention or treatment.

How similar studies have performed: Prior research has linked intermittent hypoxia and inflammasome activation including NLRP3 to inflammation and cognitive effects in OSA, but direct clinical correlations involving EGR2 and adipose tissue sampling remain relatively novel.

Eligibility criteria

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

Where this trial is running

Shanghai

• Shanghai Xinhua hospital — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Jiang, PHD,MD

Conditions: Obstructive Sleep Apnea-Hypopnea Syndrome, Anxiety Disorders, Depressive Disorders