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NCT Number: NCT06850220

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

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.

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Key information

Conditions

Pediatric Obstructive Sleep Apnea Apnea Cognition Dyssomnias EEG Empathy Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215233, China

Location status: Recruiting

Location contact

Tingyu Rong

CONTACT

[email protected]

15335273857

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

  2. Empathy Level Measured by the Pain Empathy Paradigm

    Time frame: 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.

  3. Parent-Reported Executive Function Using BRIEF-P Questionnaire

    Time frame: 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.

  4. Working Memory Assessed by WPPSI-IV or WISC-IV

    Time frame: 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 outcomes

  1. Obstructive Apnea-Hypopnea Index (OAHI) Measured by PSG

    Time frame: 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).

  2. Minimum Oxygen Saturation (MinSaO2) During Sleep

    Time frame: 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.

  3. Parent-Reported Sleep Habits Using CSHQ Questionnaire

    Time frame: 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.

  4. Theta Wave Intensity in Prefrontal Cortex During Executive Function Tasks

    Time frame: 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.

Other outcomes

  1. Theta/Beta Ratio in Resting-State EEG

    Time frame: Baseline, 6 months, and 12 months

    The theta/beta ratio in resting-state EEG will be measured as a potential biomarker for cognitive and emotional regulation in children with OSA.

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

    Time frame: Baseline, 6 months, and 12 months

    EEG will be used to measure event-related potentials (N2 and LPP) during empathy tasks, reflecting neural responses to emotional stimuli.

Study contacts

Contact information is provided by the study sponsor or research team.

Tingyu Rong, Doctor

CONTACT

[email protected]

+8615335273857

Sponsors and collaborators

Lead sponsor

Children's Hospital of Soochow University

Other

Registry information

Acronym: OSA-EFED

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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