RecruitingNot Applicable

Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children

China150 participantsStarted 2025-10-13

Plain-language 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.

Who can participate

Age range

3 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Executive function measured by the "Heart and Flower" task.

Timeframe: Baseline, 6 months, and 12 months

Empathy Level Measured by the Pain Empathy Paradigm

Timeframe: Baseline, 6 months, and 12 months

Parent-Reported Executive Function Using BRIEF-P Questionnaire

Timeframe: Baseline, 6 months, and 12 months

Working Memory Assessed by WPPSI-IV or WISC-IV

Timeframe: Baseline, 6 months, and 12 months

Trial details

NCT IDNCT06850220

SponsorChildren's Hospital of Soochow University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06-30

Contact for this trial

Tingyu Rong, Doctor

+8615335273857 tyrong@suda.edu.cn

View on ClinicalTrials.gov More Pediatric Obstructive Sleep Apnea trials

Plain-language summary

Who can participate

Age range

3 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Executive function measured by the "Heart and Flower" task.

Timeframe: Baseline, 6 months, and 12 months

Empathy Level Measured by the Pain Empathy Paradigm

Timeframe: Baseline, 6 months, and 12 months

Parent-Reported Executive Function Using BRIEF-P Questionnaire

Timeframe: Baseline, 6 months, and 12 months

Working Memory Assessed by WPPSI-IV or WISC-IV

Timeframe: Baseline, 6 months, and 12 months