Obstructive Sleep Apnea of ChildNCT05115968
Single Cell Sequencing of Tonsillar Tissue in Children With OSA
An observational study of Obstructive Sleep Apnea of Child, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Obstructive Sleep Apnea of Child
- What is being tested?
- Tonsillectomy
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2023to 30 Jun 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Previous upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, congenital or acquired immunodeficiency, known metabolic syndrome, craniofacial abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea of Child
- Being tested
- Tonsillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonsillectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Tonsillectomy | |
| Control | Non-OSA subjects (with PSG OAHI <1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis. Receives: Procedure: Tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tonsil cell characteristics
Cells characteristics by single-cell sequencing of the adenotonsillar tissue in children with OSA.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Jan 2023
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of ChildStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Ching Ching Chan, Chinese University of Hong Kong
- Investigators
- Kate C Chan, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115968
- Sponsor's protocol ID
- SCSAT_protocol_version 1.0
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2021
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No