Long-term follow-up of children with obstructive sleep apnea after adenotonsillectomy
Long-term Follow-up of Children With Obstructive Sleep Apnoea Treated With Adenotonsillectomy: Cardiovascular Perspectives
This study is trying to see if kids with obstructive sleep apnea who had their tonsils and adenoids removed have better heart health compared to those who didn't have the surgery and healthy kids without sleep apnea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 10 Years to 21 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 2 sites (Hong Kong, Kowloon and 1 other locations) |
| Trial ID | NCT04473066 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the cardiovascular outcomes of children diagnosed with obstructive sleep apnea (OSA) who underwent adenotonsillectomy (AT) compared to those who did not receive the surgery and to healthy controls without OSA. The study will assess various cardiovascular risk factors, including ambulatory blood pressure, cardiac function, and carotid artery thickness, approximately five years post-surgery. It involves a two-centre prospective case-control design, recruiting participants from two hospitals in Hong Kong. The study seeks to determine if AT leads to improved cardiovascular health in children with OSA.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5-12 years diagnosed with moderate-to-severe obstructive sleep apnea who have undergone adenotonsillectomy.
Not a fit: Patients who have not been diagnosed with obstructive sleep apnea or those with additional medical conditions affecting cardiovascular health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term cardiovascular health of children treated for obstructive sleep apnea, potentially guiding future treatment approaches.
How similar studies have performed: Previous studies have indicated potential benefits of adenotonsillectomy in improving health outcomes in children with obstructive sleep apnea, suggesting this approach has been explored but may still yield novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hong Kong, Kowloon and 1 other locations
- Department of Paediatrics, Kwong Wah Hospital — Hong Kong, Kowloon, Hong Kong (Recruiting)
- Department of Paediatrics, The Chinese University of Hong Kong — Sha Tin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Chun Ting Au, PhD — junau@cuhk.edu.hk
- Study coordinator: Chun Ting Au, PhD
- Email: junau@cuhk.edu.hk
- Phone: +852-35052917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.