Status:
RECRUITING
Long-term Follow-up of Children With OSA Treated With AT
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
10-21 years
Brief 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 di...
Detailed Description
Aims and Hypotheses to be Tested: The primary aim of this study is to assess cardiovascular outcomes of children with OSA at a mean of 5 years after they had undergone AT, compared to OSA children wi...
Eligibility Criteria
Inclusion
- General inclusion criteria:
- Participants and their parents must understand Chinese;
- Aged 5-12 years at diagnosis.
- Inclusion criteria for AT group:
- Previously diagnosed with moderate-to-severe OSA (OAHI ≥3/h);
- Tonsillar hypertrophy (tonsil grade ≥2);
- Underwent AT.
- Inclusion criteria for Refused AT group:
- Previously diagnosed with moderate-to-severe OSA (OAHI ≥3/h);
- Tonsillar hypertrophy (tonsil grade ≥2);
- Refused AT.
- Inclusion criteria for Normal Control group:
- Previously confirmed to have no OSA (OAHI \<1/h);
- Reported to have no habitual snoring (less than 3 nights per week).
- Exclusion Criteria:
- Additional upper airway surgery other than the one done at baseline visit;
- Known medical conditions that affects the cardiovascular system;
- Any use of medications that alters cardiovascular system.
Exclusion
Key Trial Info
Start Date :
July 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04473066
Start Date
July 19 2021
End Date
July 1 2024
Last Update
February 7 2024
Active Locations (2)
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1
Department of Paediatrics, Kwong Wah Hospital
Hong Kong, Kowloon, Hong Kong
2
Department of Paediatrics, The Chinese University of Hong Kong
Shatin, Hong Kong