Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pediatric Obstructive Sleep Apnea, Cognition, Empathy, EEG. Basic parameters: 3 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Executive function measured by the "Heart and Flower" task. [Time frame: Baseline, 6 months, and 12 months]
- Empathy Level Measured by the Pain Empathy Paradigm [Time frame: Baseline, 6 months, and 12 months]
- Parent-Reported Executive Function Using BRIEF-P Questionnaire [Time frame: Baseline, 6 months, and 12 months]
- Working Memory Assessed by WPPSI-IV or WISC-IV [Time frame: Baseline, 6 months, and 12 months]
Secondary outcome measures (4)
- Obstructive Apnea-Hypopnea Index (OAHI) Measured by PSG [Time frame: Baseline, 6 months, and 12 months]
- Minimum Oxygen Saturation (MinSaO2) During Sleep [Time frame: Baseline, 6 months, and 12 months]
- Parent-Reported Sleep Habits Using CSHQ Questionnaire [Time frame: Baseline, 6 months, and 12 months]
- Theta Wave Intensity in Prefrontal Cortex During Executive Function Tasks [Time frame: Baseline, 6 months, and 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Children's Hospital of Soochow University — Suzhou
Identifiers
NCT: NCT06850220 · 2024005