- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05115968
Single Cell Sequencing of Tonsillar Tissue in Children With OSA
Single Cell Sequencing to Examine the Pathogenesis of Adenotonsillar Hypertrophy in Children With Obstructive Sleep Apnoea
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.
Adenotonsillar 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kate C Chan, MBChB
- Phone Number: 35052840
- Email: katechan@cuhk.edu.hk
Study Contact Backup
- Name: Elly Cheung
- Phone Number: 35052840
- Email: ellycheung@cuhk.edu.hk
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- Prince of Wales Hospital
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Contact:
- Kate Ching Ching Chan, MD
- Phone Number: 35052861
- Email: katechan@cuhk.edu.hk
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Principal Investigator:
- Kate Ching Ching Chan, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Control: Non-OSA subjects (with PSG OAHI <1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis.
Description
Inclusion Criteria:
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.
Control: Non-OSA subjects (with PSG OAHI <1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis.
Exclusion Criteria:
Previous upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, congenital or acquired immunodeficiency, known metabolic syndrome, craniofacial abnormalities.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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OSA 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.
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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.
|
|
Control
Non-OSA subjects (with PSG OAHI <1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tonsil cell characteristics
Time Frame: Through study completion, an average of 2 years
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Cells characteristics by single-cell sequencing of the adenotonsillar tissue in children with OSA.
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Through study completion, an average of 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kate C Chan, MBChB, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCSAT_protocol_version 1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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