Long-term Follow-up of Children With OSA Treated With AT

NCT04473066 | Recruiting

• 1 other identifier: HMRF-07181276
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea, adenotonsillectomy, cardiovascular

Outcome Measures

Primary Outcomes (4)

• 24-hour ambulatory blood pressure measurements

  All subjects will undergo 24-hour ABPM on the same day as PSG. An validated oscillometric monitor (SpaceLabs 90217, SpaceLabs Medical, Redmond, Washington, USA) will be used. Systolic, diastolic and mean arterial BP will be measured every half-hourly during the period starting from 2200h to 0800h (nighttime period) and every 15 minutes outside of this period (daytime period). The exact cutoff time dividing wake and sleep BP will be defined individually according to the concurrent sleep study. The proper cuff (cuff size should have a bladder width that is approximately 40% of the arm circumference midway between the olecranon and the acromion precesses) is chosen according to the length of the arm of the subject and it will be placed in the nondominant arm of the child.

  At a mean of 5 years after intervention

• Cardiac function

  Based on M-mode assessment of the parasternal short-axis view at the mid-ventricular level, the left ventricular (LV) wall thickness and interventricular septum thickness at end-diastole will be determined. The fractional shortening and LV mass will be calculated according to standard formulae. The pulmonary arterial pressure will be estimated using the tricuspid regurgitation (TR) jet and pulmonary artery acceleration time. Tissue Doppler echocardiography will be performed with the sample volume positioned at the basal right ventricular (RV) and LV free-wall and interventricular septal annular junction. Speckle-tracking echocardiography will be performed for evaluation of myocardial deformation.

  At a mean of 5 years after intervention

• Carotid intima-media thickness

  The intima-media thickness (IMT) of the right and left common carotid arteries far wall at about 10 mm proximal to the carotid bulb will be measured using a 7 to 15-MHz high frequency linear-array transducer. Intima-media thickness of bilateral common carotid arteries will be automatically measured with electronic callipers. The average of three measurements from each side will be used for further analyses.

  At a mean of 5 years after intervention

• Arterial stiffness

  Carotid arterial stiffness of the right and left carotid arteries at about 10 mm proximal to the carotid bulb will be determined by calculation of the stiffness index.\[41\] Measurements of the end-diastolic (Dd) and systolic (Ds) diameters will be obtained between the far wall and near wall intima. For each systolic and diastolic diameter, three measurements from each side will be averaged and the means will be subsequently used in the calculation of the stiffness index as ln (SBP/DBP)/(ΔD/D), where SBP is right brachial systolic blood pressure, DBP is right brachial diastolic blood pressure, ΔD is the difference between systolic and diastolic diameters, and D is the diastolic diameter.

  At a mean of 5 years after intervention

Study Arms (3)

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.

Procedure: Adenotonsillectomoy +/- turbinate reduction

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.

Interventions

Adenotonsillectomoy +/- turbinate reduction PROCEDURE

Tonsillectomies were performed by bipolar electrocautery while adenoidectomies were done by monopolar suction diathermy. Turbinate reduction (by either submucosal bipolar diathermy or radiofrequency) would be offered if the subject had on-going history of allergic rhinitis and examination revealed at least grade II turbinate hypertrophy. (Grade I = no turbinate hypertrophy; Grade II = turbinate hypertrophy without touching the septum; Grade III = turbinate hypertrophy touching the septum).

Adenotonsillectomy (AT)

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Potential subjects for this follow-up study have been identified from two local hospitals, Prince of Wales Hospital and Kwong Wah Hospital. Since 2012, a total of 193 candidates for AT have been identified, of whom 130 underwent AT, whilst the remaining 63 (33%) preferred more conservative treatment. Non-snoring controls have been identified in several of our previous studies that involved normal controls, including OSA family study and primary snoring follow-up study, and an ongoing study which validates a prediction model for childhood OSA. At the time of writing, a total of 258 non-snoring controls have been identified from various studies since 2012.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Department of Paediatrics, Kwong Wah Hospital

Hong Kong, Kowloon, Hong Kong

RECRUITING

Department of Paediatrics, The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Chun Ting Au, PhD

  junau@cuhk.edu.hk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Ting Au, PhD

CONTACT

+852-35052917; junau@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: July 19, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

HK (2)