Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-26 @ 5:16 PM
Study NCT ID:
NCT05115968
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2021-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Cell Sequencing of Tonsillar Tissue in Children With OSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014068', 'term': 'Tonsillectomy'}], 'ancestors': [{'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tonsillar tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2021-11-07', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tonsil cell characteristics', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Cells characteristics by single-cell sequencing of the adenotonsillar tissue in children with OSA.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea of Child']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnoea (OSA) in children is a prevalent sleep disorder, and is characterised by repetitive complete or partial upper airway obstruction during sleep. It is an important disease as it is associated with a large spectrum of end-organ morbidities.\n\nAdenotonsillar hypertrophy is the commonest cause of OSA in children, however, the cause of the lymphoid tissue hypertrophy in some individuals but not the others remains unknown. To address the cellular heterogeneity and immune cell involvement in adenotonsillar hypertrophy, here, we propose to employ single-cell sequencing analysis to identify the cell-specific expression patterns associated with the disease, which will enhance our understanding of the pathogenesis of tonsillar hypertrophy in children with OSA and may provide directions for development of novel therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Case: Chinese children aged 6-11 years old with habitual snoring (≥3 nights per week) and polysomnography (PSG) confirmed OSA (obstructive apnoea hypopnoea index (OAHI) of ≥1/hour), with adenotonsillar hypertrophy and clinical indications for adenotonsillectomy will be recruited as cases.\n\nControl: Non-OSA subjects (with PSG OAHI \\<1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCase: Chinese children aged 6-11 years old with habitual snoring (≥3 nights per week) and polysomnography (PSG) confirmed OSA (obstructive apnoea hypopnoea index (OAHI) of ≥1/hour), with adenotonsillar hypertrophy and clinical indications for adenotonsillectomy will be recruited as cases.\n\nControl: Non-OSA subjects (with PSG OAHI \\<1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis.\n\nExclusion Criteria:\n\nPrevious upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, congenital or acquired immunodeficiency, known metabolic syndrome, craniofacial abnormalities.'}, 'identificationModule': {'nctId': 'NCT05115968', 'briefTitle': 'Single Cell Sequencing of Tonsillar Tissue in Children With OSA', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Single Cell Sequencing to Examine the Pathogenesis of Adenotonsillar Hypertrophy in Children With Obstructive Sleep Apnoea', 'orgStudyIdInfo': {'id': 'SCSAT_protocol_version 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OSA case', 'description': 'Chinese children aged 6-11 years old with habitual snoring (≥3 nights per week) and polysomnography (PSG) confirmed OSA (obstructive apnoea hypopnoea index (OAHI) of ≥1/hour), with adenotonsillar hypertrophy and clinical indications for adenotonsillectomy will be recruited as cases.', 'interventionNames': ['Procedure: Tonsillectomy']}, {'label': 'Control', 'description': 'Non-OSA subjects (with PSG OAHI \\<1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis.', 'interventionNames': ['Procedure: Tonsillectomy']}], 'interventions': [{'name': 'Tonsillectomy', 'type': 'PROCEDURE', 'description': 'Subjects who are diagnosed to have OSA with adeontonsillar enlargement will undergo adenotonsillectomy if it is clinically indicated. Adenotonsillar tissue will be obtained for single cell sequencing. Controls will be non-OSA subjects (with PSG OAHI \\<1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis.', 'armGroupLabels': ['Control', 'OSA case']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Kate Ching Ching Chan, MD', 'role': 'CONTACT', 'email': 'katechan@cuhk.edu.hk', 'phone': '35052861'}, {'name': 'Kate Ching Ching Chan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Kate C Chan, MBChB', 'role': 'CONTACT', 'email': 'katechan@cuhk.edu.hk', 'phone': '35052840'}, {'name': 'Elly Cheung', 'role': 'CONTACT', 'email': 'ellycheung@cuhk.edu.hk', 'phone': '35052840'}], 'overallOfficials': [{'name': 'Kate C Chan, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professional Consultant', 'investigatorFullName': 'Kate Ching Ching Chan', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}