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

NCT ID: NCT06850220

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-13
• Study Completion Date: 2027-06-30

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.

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.

Conditions

Pediatric Obstructive Sleep Apnea; Cognition; Empathy; EEG

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Moderate OSA Group

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

No interventions assigned to this group

Severe OSA Group

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Ying Wu

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tingyu Rong, Doctor

Role: CONTACT

tyrong@suda.edu.cn

+8615335273857

Facility Contacts

Tingyu Rong

Role: primary

tyrong@suda.edu.cn

15335273857

Other Identifiers

2024005

Identifier Type: -

Identifier Source: org_study_id