NCT05115968

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

September 22, 2021

Last Update Submit

February 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Procedure: Tonsillectomy

Control

Non-OSA subjects (with PSG OAHI \<1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis.

Procedure: Tonsillectomy

Interventions

TonsillectomyPROCEDURE

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.

ControlOSA case

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Previous upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, congenital or acquired immunodeficiency, known metabolic syndrome, craniofacial abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tonsillar tissue

MeSH Terms

Interventions

Tonsillectomy

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Kate C Chan, MBChB

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate C Chan, MBChB

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professional Consultant

Study Record Dates

First Submitted

September 22, 2021

First Posted

November 10, 2021

Study Start

January 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations