Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children (OSA-EFED)

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.

Study Overview

• Status: Recruiting
• Conditions: Cognition; Empathy; EEG; Pediatric Obstructive Sleep Apnea

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Tingyu Rong, Doctor; Phone Number: +8615335273857; Email: tyrong@suda.edu.cn

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215233
      • Recruiting
      • Children's Hospital of Soochow University
      • Contact: Tingyu Rong; Phone Number: 15335273857; Email: tyrong@suda.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children aged 3-12 years diagnosed with OSA and healthy controls.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Children's Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 23, 2025
• First Submitted That Met QC Criteria: February 23, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Children; Obstructive Sleep Apnea; Executive Function; Neurodevelopment; Adenotonsillectomy; Empathy; Cohort Study; EEG Biomarkers
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2024005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No