Obstructive Sleep Apnea-Hypopnea SyndromeNCT07120711
EGR2 and NLRP3 Pathways in Obstructive Sleep Apnea-Related Cognitive and Mood Disorders
An observational study of Obstructive Sleep Apnea-Hypopnea Syndrome and Anxiety Disorders, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea-Hypopnea Syndrome, Anxiety Disorders, Depressive Disorders
- What is being tested?
- EGR2/NLRP3 pathway activity and fatty tissue
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: his observational study will enroll both pediatric and adult participants with obstructive sleep apnea-hypopnea syndrome (OSAS) alongside age-matched healthy controls. Specifically: Pediatric cohort (2-18 years): Four age strata (2-6, 7-9, 10-12, 13-18 years), each with 50 OSAS patients and 50 healthy controls. Adult cohort (>18 years): Four age strata (18-40, 41-60, 61-80, >80 years), each with 50 OSAS patients and 50 healthy controls. Participants will be recruited from the ENT outpatient and sleep/respiratory clinics of Shanghai Xinhua Hospital and the MED-X Research Institute, Shanghai Jiao Tong University, between July 2025 and September 2026.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Xinhua hospital
Shanghai
Jiang, +86 13817719616, jianglaimz@sina.com
About this study
Official title: Regulatory Mechanisms of EGR2 and NLRP3 Inflammatory Pathways in Cognitive Impairment and Depressive-Anxiety-Like Behaviors Associated With Obstructive Sleep Apnea-Hypopnea Syndrome
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:
Read more
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.
- Being tested
- EGR2/NLRP3 pathway activity, fatty tissue
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGR2/NLRP3 pathway activityProcedure or surgery
Peripheral blood collection \& PBMC isolation:
Children: 3 mL venous blood drawn from the right antecubital vein preoperatively; Adults: 3 mL fasting venous blood drawn the morning after PSG.
Collected in EDTA tubes; PBMCs separated via Ficoll-Paque density gradient. Flow cytometry: 1×10⁶ PBMCs stained for CD14/CD16, HLA-DR, CD11b, CD80/CD86, CD163/CD206.
RNA extraction: Remaining PBMCs lysed in TRIzol and stored at -80 °C for RT-qPCR of EGR2, NLRP3, and downstream genes Serum/plasma: Within 1 h of collection, centrifuge at 400 × g for 10 min at 4 °C; 1 mL used for ELISA quantification of TNF-α, IL-6, IL-1β, CCL2, IL-17, CRP; remainder stored at -80 °C for future proteomic or metabolomic assays
Saliva sampling \& processing:
2-3 mL unstimulated saliva expectorated into sterile tubes, kept at 4 °C, processed (centrifuged, aliquoted) within 2 h, then stored at -80 °C.
fatty tissueProcedure or surgery
Subcutaneous fat biopsy (adults undergoing surgery):
100-200 mg obtained intraoperatively, placed in RNAlater at 4 °C for 24 h, then frozen at -80 °C for downstream RNA-seq, RT-qPCR, and Western blot analyses of EGR2, NLRP3, and related inflammatory markers
| Study group | Role | What they receive |
|---|---|---|
| OSAS_chlidren | Not described Receives: Procedure: EGR2/NLRP3 pathway activity | |
| OSAS_adult | Not described Receives: Procedure: EGR2/NLRP3 pathway activity; Procedure: fatty tissue | |
| non_OSAS_chlidren | Not described Receives: Procedure: EGR2/NLRP3 pathway activity | |
| non_OSAS_adult | Not described Receives: Procedure: EGR2/NLRP3 pathway activity; Procedure: fatty tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of EGR2 and NLRP3 in PBMCs, saliva, and subcutaneous fat tissue
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
Measured: Jul 2025 - Sep 2026
Secondary outcomes (1)
Multi-omics association of molecular markers with clinical phenotypes
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.
Measured: Jul 2025 - Sep 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Jul 2025
- Primary completion22 Jul 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea-Hypopnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai Jiang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120711
- Sponsor's protocol ID
- XHEC-C-2025-163-1
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Mechanisms of EGR2 and NLRP3 Inflammatory Pathways in Cognitive Impairment and Depressive-Anxiety-Like Behaviors Associated With Obstructive Sleep Apnea-Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT07120711
- Acronym / sponsor ID
- XHEC-C-2025-163-1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OSAS_chlidren | – | Procedure: EGR2/NLRP3 pathway activity |
| OSAS_adult | – | Procedure: EGR2/NLRP3 pathway activity, Procedure: fatty tissue |
| non_OSAS_chlidren | – | Procedure: EGR2/NLRP3 pathway activity |
| non_OSAS_adult | – | Procedure: EGR2/NLRP3 pathway activity, Procedure: fatty tissue |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- his observational study will enroll both pediatric and adult participants with obstructive sleep apnea-hypopnea syndrome (OSAS) alongside age-matched healthy controls. Specifically: Pediatric cohort (2-18 years): Four age strata (2-6, 7-9, 10-12, 13-18 years), each with 50 OSAS patients and 50 healthy controls. Adult cohort (>18 years): Four age strata (18-40, 41-60, 61-80, >80 years), each with 50 OSAS patients and 50 healthy controls. Participants will be recruited from the ENT outpatient and sleep/respiratory clinics of Shanghai Xinhua Hospital and the MED-X Research Institute, Shanghai Jiao Tong University, between July 2025 and September 2026.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGR2/NLRP3 pathway activityPeripheral blood collection \& PBMC isolation: Children: 3 mL venous blood drawn from the right antecubital vein preoperatively; Adults: 3 mL fasting venous blood drawn the morning after PSG. Collected in EDTA tubes; PBMCs separated via Ficoll-Paque density gradient. Flow cytometry: 1×10⁶ PBMCs stained for CD14/CD16, HLA-DR, CD11b, CD80/CD86, CD163/CD206. RNA extraction: Remaining PBMCs lysed in TRIzol and stored at -80 °C for RT-qPCR of EGR2, NLRP3, and downstream genes Serum/plasma: Within 1 h of collection, centrifuge at 400 × g for 10 min at 4 °C; 1 mL used for ELISA quantification of TNF-α, IL-6, IL-1β, CCL2, IL-17, CRP; remainder stored at -80 °C for future proteomic or metabolomic assays Saliva sampling \& processing: 2-3 mL unstimulated saliva expectorated into sterile tubes, kept at 4 °C, processed (centrifuged, aliquoted) within 2 h, then stored at -80 °C. | Procedure or surgery | OSAS_adult, OSAS_chlidren, non_OSAS_adult, non_OSAS_chlidren |
| fatty tissueSubcutaneous fat biopsy (adults undergoing surgery): 100-200 mg obtained intraoperatively, placed in RNAlater at 4 °C for 24 h, then frozen at -80 °C for downstream RNA-seq, RT-qPCR, and Western blot analyses of EGR2, NLRP3, and related inflammatory markers | Procedure or surgery | OSAS_adult, non_OSAS_adult |
Primary outcome
Expression levels of EGR2 and NLRP3 in PBMCs, saliva, and subcutaneous fat tissue
Time frame: 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
1 secondary outcome
Multi-omics association of molecular markers with clinical phenotypes
Time frame: Jul 2025 - Sep 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea-Hypopnea Syndrome and Anxiety Disorders, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiang, PHD,MD (13817719616, jianglaimz@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of EGR2 and NLRP3 in PBMCs, saliva, and subcutaneous fat tissue (time frame: Jul 2025 - Sep 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.