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This study aims to investigate the effects of obstructive sleep apnea (OSA) on executive function and empathy development in children aged 3-12 years. The study will compare the outcomes of different treatment approaches (surgical vs. pharmacological) in children with mild OSA and track the progression of cognitive and emotional functions over 12 months. The study will also explore potential EEG biomarkers for assessing neurological damage in OSA children.
This is a prospective observational cohort study conducted at the Sleep Center of the Respiratory Department and the Department of Child and Adolescent Healthcare, Children's Hospital of Soochow University. Children diagnosed with OSA will be divided into groups based on disease severity (mild, moderate, severe) and treatment choice (surgical or pharmacological). The study will assess executive function and empathy levels at baseline, 6 months, and 12 months post-intervention using behavioral tests, EEG, and parent-reported questionnaires. The study aims to provide evidence for treatment selection in mild OSA children and identify EEG biomarkers for neurological damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild OSA - Surgical Treatment Group | Children aged 3-12 years diagnosed with mild OSA (1 < OAHI ≤ 5 events/hour) who undergo adenotonsillectomy as the primary treatment. | ||
| Mild OSA - Pharmacological Group | Children aged 3-12 years diagnosed with mild OSA (1 < OAHI ≤ 5 events/hour) who receive conservative treatment with nasal corticosteroids and leukotriene receptor antagonists. | ||
| Moderate OSA Group | Children aged 3-12 years diagnosed with moderate OSA (5 < OAHI ≤ 10 events/hour) who undergo adenotonsillectomy as the primary treatment. | ||
| Severe OSA Group | Children aged 3-12 years diagnosed with severe OSA (OAHI > 10 events/hour) who undergo adenotonsillectomy as the primary treatment. | ||
| Healthy Control Group | Healthy children aged 3-12 years with no history of OSA or other sleep disorders. This group serves as a control for comparison. |
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| Measure | Description | Time Frame |
|---|---|---|
| Executive function measured by the "Heart and Flower" task. | Children's executive function will be assessed using the "Heart and Flower" task, which measures the ability to follow rules and switch between tasks. Performance is evaluated based on accuracy and reaction time. | Baseline, 6 months, and 12 months |
| Empathy Level Measured by the Pain Empathy Paradigm | Children's empathy level will be assessed using a pain empathy paradigm, where children rate the pain intensity of others in pictures. Scores reflect their ability to understand and share the feelings of others. | Baseline, 6 months, and 12 months |
| Parent-Reported Executive Function Using BRIEF-P Questionnaire | Parents will complete the BRIEF-P to assess their child's everyday executive function behaviors, including inhibition, emotional control, and working memory. | Baseline, 6 months, and 12 months |
| Working Memory Assessed by WPPSI-IV or WISC-IV | Children's working memory will be assessed using the WPPSI-IV or WISC-IV, depending on the child's age. | Baseline, 6 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Obstructive Apnea-Hypopnea Index (OAHI) Measured by PSG | The OAHI, which measures the number of obstructive apnea and hypopnea events per hour during sleep, will be assessed using polysomnography (PSG). | Baseline, 6 months, and 12 months |
| Minimum Oxygen Saturation (MinSaO2) During Sleep |
| Measure | Description | Time Frame |
|---|---|---|
| Theta/Beta Ratio in Resting-State EEG | The theta/beta ratio in resting-state EEG will be measured as a potential biomarker for cognitive and emotional regulation in children with OSA. | Baseline, 6 months, and 12 months |
| Event-Related Potentials (N2 and LPP) During Empathy Tasks |
Inclusion Criteria:
Exclusion Criteria:
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Children aged 3-12 years diagnosed with OSA and healthy controls.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingyu Rong, Doctor | Contact | +8615335273857 | tyrong@suda.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215233 | China |
Individual participant data will not be shared to protect participant privacy and confidentiality, as the data contains sensitive information related to children's health and neuropsychological development.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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The minimum oxygen saturation level during sleep will be measured using PSG to assess the severity of oxygen desaturation in OSA children. |
| Baseline, 6 months, and 12 months |
| Parent-Reported Sleep Habits Using CSHQ Questionnaire | Parents will complete the CSHQ to report their child's sleep behaviors, including bedtime resistance, sleep duration, and night awakenings. | Baseline, 6 months, and 12 months |
| Theta Wave Intensity in Prefrontal Cortex During Executive Function Tasks | EEG will be used to measure theta wave intensity in the prefrontal cortex while children perform executive function tasks, providing an objective neural correlate of executive function. | Baseline, 6 months, and 12 months |
EEG will be used to measure event-related potentials (N2 and LPP) during empathy tasks, reflecting neural responses to emotional stimuli. |
| Baseline, 6 months, and 12 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |