Single Cell Sequencing of Tonsillar Tissue in Children With OSA

Obstructive Sleep Apnea of Child Clinical Trial

Official title:

Single Cell Sequencing to Examine the Pathogenesis of Adenotonsillar Hypertrophy in Children With Obstructive Sleep Apnoea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05115968
• Other study ID #: SCSAT_protocol_version 1.0
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Chinese University of Hong Kong
• Contact: Kate C Chan, MBChB
• Phone: 35052840
• Email: katechan[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Child
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Tonsillectomy
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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tonsil cell characteristics	Cells characteristics by single-cell sequencing of the adenotonsillar tissue in children with OSA.	Through study completion, an average of 2 years