Pediatric Obstructive Sleep ApneaOSA-EFEDNCT06850220
Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children
An observational study of Pediatric Obstructive Sleep Apnea and Cognition, run by Children's Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obstructive Sleep Apnea, Cognition, Empathy
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 3-12 years diagnosed with OSA and healthy controls.
Who may be able to join
- Children aged 3-12 years.
- Diagnosed with OSA due to adenoid and/or tonsillar hypertrophy.
- IQ ≥ 85.
- Parental consent for participation.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Soochow University
Suzhou, Jiangsu, 215233
Tingyu Rong, 15335273857, tyrong@suda.edu.cn
About this study
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.
Read the 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
- Keywords
- Obstructive Sleep Apnea, Executive Function, Empathy, Children, EEG Biomarkers, Cohort Study, Neurodevelopment, Adenotonsillectomy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (4)
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).
Measured: Baseline, 6 months, and 12 months
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.
Measured: Baseline, 6 months, and 12 months
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.
Measured: Baseline, 6 months, and 12 months
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.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start13 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Wu, Children's Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850220
- Sponsor's protocol ID
- 2024005
- Acronym
- OSA-EFED
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality, as the data contains sensitive information related to children's health and neuropsychological development.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children
- ClinicalTrials.gov ID
- NCT06850220
- Acronym / sponsor ID
- OSA-EFED / 2024005
- Conditions
- Pediatric Obstructive Sleep Apnea, Cognition, Empathy, EEG
- Keywords
- Obstructive Sleep Apnea, Executive Function, Empathy, Children, EEG Biomarkers, Cohort Study, Neurodevelopment, Adenotonsillectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Children's Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 3-12 years diagnosed with OSA and healthy controls.
Key inclusion criteria (4 listed)
- Children aged 3-12 years.
- Diagnosed with OSA due to adenoid and/or tonsillar hypertrophy.
- IQ ≥ 85.
- Parental consent for participation.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Obstructive Apnea-Hypopnea Index (OAHI) Measured by PSG
Time frame: Baseline, 6 months, and 12 months
Minimum Oxygen Saturation (MinSaO2) During Sleep
Time frame: Baseline, 6 months, and 12 months
Parent-Reported Sleep Habits Using CSHQ Questionnaire
Time frame: Baseline, 6 months, and 12 months
Theta Wave Intensity in Prefrontal Cortex During Executive Function Tasks
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality, as the data contains sensitive information related to children's health and neuropsychological development.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obstructive Sleep Apnea and Cognition, run by Children's Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingyu Rong, Doctor (+8615335273857, tyrong@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive function measured by the "Heart and Flower" task. (time frame: Baseline, 6 months, and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.