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

NCT06850220 | Recruiting DMC

• 1 other identifier: 2024005
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

EEG; Pediatric Obstructive Sleep Apnea; Cognition; Empathy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Obstructive Apnea-Hypopnea Index (OAHI) Measured by PSG

  Baseline, 6 months, and 12 months

• Minimum Oxygen Saturation (MinSaO2) During Sleep

  Baseline, 6 months, and 12 months

• Parent-Reported Sleep Habits Using CSHQ Questionnaire

  Baseline, 6 months, and 12 months

• Theta Wave Intensity in Prefrontal Cortex During Executive Function Tasks

  Baseline, 6 months, and 12 months

Other Outcomes (2)

• Theta/Beta Ratio in Resting-State EEG

  Baseline, 6 months, and 12 months

• Event-Related Potentials (N2 and LPP) During Empathy Tasks

  Baseline, 6 months, and 12 months

Study Arms (5)

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.

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Soochow University: lead

Study Sites (1)

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215233, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Tingyu Rong, Doctor

CONTACT

+8615335273857; tyrong@suda.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)