Clinical trial NCT06850220: Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children
Official title: Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pediatric Obstructive Sleep Apnea
Cognition
Empathy
EEG
Keywords: Obstructive Sleep Apnea
Executive Function
Empathy
Children
EEG Biomarkers
Cohort Study
Neurodevelopment
Adenotonsillectomy
Lead sponsor: Children's Hospital of Soochow University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 3-12 years diagnosed with OSA and healthy controls.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children aged 3-12 years.
* Diagnosed with OSA due to adenoid and/or tonsillar hypertrophy.
* IQ ≥ 85.
* Parental consent for participation.

Exclusion Criteria:

* Other primary sleep disorders (e.g., narcolepsy, restless leg syndrome).
* Developmental delay, epilepsy, or other neurological/metabolic disorders.
* Chronic diseases or history of head trauma.

Primary outcomes:
measure: Executive function measured by the "Heart and Flower" task.
timeFrame: Baseline, 6 months, and 12 months
measure: Empathy Level Measured by the Pain Empathy Paradigm
timeFrame: Baseline, 6 months, and 12 months
measure: Parent-Reported Executive Function Using BRIEF-P Questionnaire
timeFrame: Baseline, 6 months, and 12 months
measure: Working Memory Assessed by WPPSI-IV or WISC-IV
timeFrame: Baseline, 6 months, and 12 months
Secondary outcomes:
measure: Obstructive Apnea-Hypopnea Index (OAHI) Measured by PSG
timeFrame: Baseline, 6 months, and 12 months
measure: Minimum Oxygen Saturation (MinSaO2) During Sleep
timeFrame: Baseline, 6 months, and 12 months
measure: Parent-Reported Sleep Habits Using CSHQ Questionnaire
timeFrame: Baseline, 6 months, and 12 months
measure: Theta Wave Intensity in Prefrontal Cortex During Executive Function Tasks
timeFrame: Baseline, 6 months, and 12 months
Other outcomes:
measure: Theta/Beta Ratio in Resting-State EEG
timeFrame: Baseline, 6 months, and 12 months
measure: Event-Related Potentials (N2 and LPP) During Empathy Tasks
timeFrame: Baseline, 6 months, and 12 months
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