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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06850220

Acronym

OSA-EFED

Enrollment

150

Registered

2025-02-27

Start date

2025-10-13

Completion date

2027-06-30

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition, EEG, Empathy, Pediatric Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, Executive Function, Empathy, Children, EEG Biomarkers, Cohort Study, Neurodevelopment, Adenotonsillectomy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Executive function measured by the "Heart and Flower" task.	Baseline, 6 months, and 12 months	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.
Empathy Level Measured by the Pain Empathy Paradigm	Baseline, 6 months, and 12 months	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.
Parent-Reported Executive Function Using BRIEF-P Questionnaire	Baseline, 6 months, and 12 months	Parents will complete the BRIEF-P to assess their child's everyday executive function behaviors, including inhibition, emotional control, and working memory.
Working Memory Assessed by WPPSI-IV or WISC-IV	Baseline, 6 months, and 12 months	Children's working memory will be assessed using the WPPSI-IV or WISC-IV, depending on the child's age.

Secondary

Measure	Time frame	Description
Obstructive Apnea-Hypopnea Index (OAHI) Measured by PSG	Baseline, 6 months, and 12 months	The OAHI, which measures the number of obstructive apnea and hypopnea events per hour during sleep, will be assessed using polysomnography (PSG).
Minimum Oxygen Saturation (MinSaO2) During Sleep	Baseline, 6 months, and 12 months	The minimum oxygen saturation level during sleep will be measured using PSG to assess the severity of oxygen desaturation in OSA children.
Parent-Reported Sleep Habits Using CSHQ Questionnaire	Baseline, 6 months, and 12 months	Parents will complete the CSHQ to report their child's sleep behaviors, including bedtime resistance, sleep duration, and night awakenings.
Theta Wave Intensity in Prefrontal Cortex During Executive Function Tasks	Baseline, 6 months, and 12 months	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.

Countries

China

Contacts

CONTACTTingyu Rong, Doctor

tyrong@suda.edu.cn+8615335273857

Outcome results