Long-term Follow-up of Children With Obstructive Sleep Apnoea Treated With Adenotonsillectomy: Cardiovascular Perspectives

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

Objectives: To assess the cardiovascular outcomes of children with obstructive sleep apnoea (OSA) at a mean of 5 years after they had undergone adenotonsillectomy (AT), compared to OSA children who did not undergo AT, and normal controls without OSA. Hypothesis to be tested: (1) children with OSA underwent AT would have lower cardiovascular risks, namely lower ambulatory blood pressure (ABP), better cardiac function, lower carotid intima-media thickness (CIMT) and lower carotid arterial thickness when compared to those with OSA but did not undergo AT, and that (2) children with OSA, despite treatment with AT, would have higher cardiovascular risks than non-OSA controls.

Design: A two-centre prospective case-control follow-up study Subjects: Potential subjects for this follow-up study have been identified from two local hospitals, Prince of Wales and Kwong Wah Hospitals. AT-treated group (n=90) - Children had moderate-to-severe OSA (obstructive apnoea hypopnoea index (OAHI) \>=3 events/h) and underwent AT when they were aged 5-12 years. Refused AT group (n=45) - Children had moderate-to-severe OSA but refused AT. Non-OSA control group (n=45) - Non-snoring controls with OAHI \<1 event/h . Main outcome measures: 24-hour ABP, cardiac function measured by echocardiography, CIMT and carotid arterial stiffness. Data analysis: Apart from group comparisons, multiple linear regression and logistic regression analysis will also be used to examine whether cardiovascular outcomes are associated with AT, pre- and post-AT OAHI while adjusted for confounders. Expected results: AT improves cardiovascular outcomes of children with OSA. However they still had higher cardiovascular risks than normal controls even after AT.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 21
Healthy Volunteers: t
View:

• Participants and their parents must understand Chinese;

• Aged 5-12 years at diagnosis.

• Previously diagnosed with moderate-to-severe OSA (OAHI ≥3/h);

• Tonsillar hypertrophy (tonsil grade ≥2);

• Underwent AT.

• Previously diagnosed with moderate-to-severe OSA (OAHI ≥3/h);

• Tonsillar hypertrophy (tonsil grade ≥2);

• Refused AT.

• Previously confirmed to have no OSA (OAHI \<1/h);

• Reported to have no habitual snoring (less than 3 nights per week).

Locations
Other Locations
Hong Kong Special Administrative Region
Department of Paediatrics, Kwong Wah Hospital
RECRUITING
Hong Kong
Department of Paediatrics, The Chinese University of Hong Kong
RECRUITING
Shatin
Contact Information
Primary
Chun Ting Au, PhD
junau@cuhk.edu.hk
+852-35052917
Time Frame
Start Date: 2021-07-19
Estimated Completion Date: 2024-07
Participants
Target number of participants: 180
Treatments
Adenotonsillectomy (AT)
Children diagnosed with moderate-to-severe OSA (OAHI ≥3/h) and tonsillar hypertrophy (tonsil grade ≥2) at the age of 5-12 years old and underwent AT since 2012.
Refused AT
Children diagnosed with moderate-to-severe OSA and tonsillar hypertrophy but refused AT in the same period.
Normal control
Children reported to have no habitual snoring (less than 3 nights per week) and confirmed to have no OSA (OAHI \<1/h) by overnight sleep study in the same period.
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov

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