Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06850220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-27
First Post:
2025-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-23', 'studyFirstSubmitDate': '2025-02-23', 'studyFirstSubmitQcDate': '2025-02-23', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Theta/Beta Ratio in Resting-State EEG', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': 'The theta/beta ratio in resting-state EEG will be measured as a potential biomarker for cognitive and emotional regulation in children with OSA.'}, {'measure': 'Event-Related Potentials (N2 and LPP) During Empathy Tasks', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': 'EEG will be used to measure event-related potentials (N2 and LPP) during empathy tasks, reflecting neural responses to emotional stimuli.'}], 'primaryOutcomes': [{'measure': 'Executive function measured by the "Heart and Flower" task.', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': '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.'}, {'measure': 'Empathy Level Measured by the Pain Empathy Paradigm', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': "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."}, {'measure': 'Parent-Reported Executive Function Using BRIEF-P Questionnaire', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': "Parents will complete the BRIEF-P to assess their child's everyday executive function behaviors, including inhibition, emotional control, and working memory."}, {'measure': 'Working Memory Assessed by WPPSI-IV or WISC-IV', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': "Children's working memory will be assessed using the WPPSI-IV or WISC-IV, depending on the child's age."}], 'secondaryOutcomes': [{'measure': 'Obstructive Apnea-Hypopnea Index (OAHI) Measured by PSG', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': 'The OAHI, which measures the number of obstructive apnea and hypopnea events per hour during sleep, will be assessed using polysomnography (PSG).'}, {'measure': 'Minimum Oxygen Saturation (MinSaO2) During Sleep', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': 'The minimum oxygen saturation level during sleep will be measured using PSG to assess the severity of oxygen desaturation in OSA children.'}, {'measure': 'Parent-Reported Sleep Habits Using CSHQ Questionnaire', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': "Parents will complete the CSHQ to report their child's sleep behaviors, including bedtime resistance, sleep duration, and night awakenings."}, {'measure': 'Theta Wave Intensity in Prefrontal Cortex During Executive Function Tasks', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'Executive Function', 'Empathy', 'Children', 'EEG Biomarkers', 'Cohort Study', 'Neurodevelopment', 'Adenotonsillectomy'], 'conditions': ['Pediatric Obstructive Sleep Apnea', 'Cognition', 'Empathy', 'EEG']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 3-12 years diagnosed with OSA and healthy controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 3-12 years.\n* Diagnosed with OSA due to adenoid and/or tonsillar hypertrophy.\n* IQ ≥ 85.\n* Parental consent for participation.\n\nExclusion Criteria:\n\n* Other primary sleep disorders (e.g., narcolepsy, restless leg syndrome).\n* Developmental delay, epilepsy, or other neurological/metabolic disorders.\n* Chronic diseases or history of head trauma.'}, 'identificationModule': {'nctId': 'NCT06850220', 'acronym': 'OSA-EFED', 'briefTitle': 'Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Soochow University"}, 'officialTitle': 'Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children', 'orgStudyIdInfo': {'id': '2024005'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.'}, {'label': '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.'}, {'label': '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.'}, {'label': 'Severe OSA Group', 'description': 'Children aged 3-12 years diagnosed with severe OSA (OAHI \\> 10 events/hour) who undergo adenotonsillectomy as the primary treatment.'}, {'label': '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.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Soochow University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Ying Wu', 'investigatorAffiliation': "Children's Hospital of Soochow University"}}}}