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

Children's Hospital of Soochow University

Status: Enrolling

Conditions: Pediatric Obstructive Sleep Apnea; EEG; Empathy; Cognition

Study type: Observational

Funder types: Other

Identifiers

NCT06850220

2024005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

150 participants in 5 patient groups

Mild OSA - Surgical Treatment Group

Description:

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

Description:

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

Description:

Children aged 3-12 years diagnosed with moderate OSA (5 \< OAHI ≤ 10 events/hour) who undergo adenotonsillectomy as the primary treatment.

Severe OSA Group

Description:

Children aged 3-12 years diagnosed with severe OSA (OAHI \> 10 events/hour) who undergo adenotonsillectomy as the primary treatment.

Healthy Control Group

Description:

Healthy children aged 3-12 years with no history of OSA or other sleep disorders. This group serves as a control for comparison.