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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-12
SponsorChildren's Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 3-12 years.

Diagnosed with OSA due to adenoid and/or tonsillar hypertrophy.

IQ ≥ 85.

Parental consent for participation.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 5 trial groups
Group A: Mild OSA - Surgical Treatment Group
Group B: Mild OSA - Pharmacological Group
Group C: Moderate OSA Group
Group D: Severe OSA Group
Group E: Healthy Control Group

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 6 months, and 12 months
2

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.

Time frame
Baseline, 6 months, and 12 months
3

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.

Time frame
Baseline, 6 months, and 12 months
4

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.

Time frame
Baseline, 6 months, and 12 months

Secondary outcomes

1

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).

Time frame
Baseline, 6 months, and 12 months
2

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.

Time frame
Baseline, 6 months, and 12 months
3

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.

Time frame
Baseline, 6 months, and 12 months
4

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.

Time frame
Baseline, 6 months, and 12 months

Other outcomes

1

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.

Time frame
Baseline, 6 months, and 12 months
2

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.

Time frame
Baseline, 6 months, and 12 months

Sponsors and contacts

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