Obstructive Sleep ApneaNCT04473066
Long-term Follow-up of Children With OSA Treated With AT
An observational study of Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Adenotonsillectomoy +/- turbinate reduction
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 2 sitesHong Kong
- Study dates
- 19 Jul 2021to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 2 recruiting
- Recruiting
Department of Paediatrics, Kwong Wah Hospital
Hong Kong, Kowloon
Ka Li Kwok, FRCPCH, +852-35175930, kwokklc@ha.org.hk
Ka Li Kwok, FRCPCH
- Recruiting
Department of Paediatrics, The Chinese University of Hong Kong
Shatin
Chun Ting Au, PhD, 35052917, junau@cuhk.edu.hk
Albert M Li, MD
About this study
Official title: Long-term Follow-up of Children With Obstructive Sleep Apnoea Treated With Adenotonsillectomy: Cardiovascular Perspectives
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.
Read more
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.
Read the 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 without surgical treatment and children without OSA. The secondary aim is to explore factors associated with cardiovascular outcomes in subjects with OSA after AT.
We hypothesise that (1) children with OSA underwent AT would have lower cardiovascular risks, namely lower ABP, better cardiac function, lower carotid intima-media thickness (CIMT) and lower carotid arterial stiffness 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.
Study design: A two-centre prospective case-control follow-up study.
Sample size estimation:
We have conducted a pilot study to compare 12 children with residual OSA after AT (defined as post-AT OAHI >=3/h) and 12 age-, sex- and BMI-matched non-snoring controls. The results showed that children with residual OSA had a higher nighttime systolic BP (NSBP) than non-snoring controls (98.9 c.f. 95.6 mm Hg, mean difference = 3.35 mmHg, common SD = 6.54 mmHg, effect size = 0.51). We have a total of 130 subjects with moderate-to-severe OSA who had undergone AT. As the main aim of this study is to assess the treatment effects of AT, we will try to recruit as many AT-treated subjects as possible. Assuming a response rate of 70%, 90 subjects will be recruited. If 45 normal controls were also recruited (case/control ratio = 2:1), the study would provide a power of 87% to detect the difference with a 5% type I error rate. The minimum number of subjects required to detect the difference with an 80% power and a 5% type I error rate are 72 cases and 36 controls if the case/control ratio is 2:1. A sample size of 90 AT-treated subjects will also provide an 80% power to detect the potential effects of pre-AT OAHI and follow-up OAHI on cardiovascular outcomes with medium effect size (assuming a partial R-squared of 0.1), while adjusted for age, sex and BMI in multiple linear regression model within the AT group.
Besides, we have also conducted a separate pilot study comparing a group of 18 children with moderate-to-severe OSA treated with AT and a group of 18 age-, sex- and BMI-matched children with similar OSA severity without AT. The results showed that the nighttime systolic BP in the AT group was reduced by a mean of 2.3 mmHg at a 9-month follow-up visit, whereas the non-AT group had an increase in nighttime systolic BP by a mean of 2.3 mmHg (mean difference = 4.52 mmHg, common SD = 7.34 mmHg, effect size = 0.62). We have a total of 63 candidates for AT who had refused to undergo AT. Assuming a response rate of 70%, 45 subjects will be recruited. A total of 90 cases (AT-treated) and 45 controls (refused AT) provides a power of 95% to detect the expected difference with a type I error rate of 5%. The minimum number of subjects required to detect the difference with an 80% power and a 5% type I error rate are 50 cases and 25 controls if the case/control ratio is 2:1. All sample size and power calculations were done using G*Power (Version 3.1.9.2).
Our target is to recruit a total of 180 subjects, comprising of 90 OSA subjects treated with AT, 45 non-snoring controls and 45 OSA subjects without AT for this follow-up study. We are confident to recruit the target number of subjects as we have been following up the OSA patients regularly in out-patient clinic and we also have a sufficient amount of normal control subjects for matching and recruitment.
Methods:
All participants will have to visit our unit once to undergo anthropometric measurement, overnight polysomnography (PSG), 24-hour ABPM, echocardiographic and arterial assessments. They will be arranged to come to our sleep laboratory at around 9 am in the morning. Twenty-four hour ABPM will be started after resting for 10 minutes upon arrival. Echocardiographic and arterial assessments will be subsequently arranged. They will stay until the next morning after completion of overnight sleep study and 24-h ABPM. For those who are reluctant to complete the whole study protocol, especially for control subjects who may not be willing to stay overnight for the sleep study, their symptoms will be documented by a self- or parent-report questionnaire (appendix 2), and they will have to come to our unit to undergo all the cardiovascular assessments and take the ABP monitor back home and return to us the next day when the 24-h monitoring is completed. Those failed to complete all the outcome assessments will be excluded.
Data processing and analysis:
The AT-treated group will be compared to the refused AT group and the non-snoring controls to assess the between-group differences in various cardiovascular outcomes. Student's t tests, Mann-Whitney U tests and chi-square tests will be used for the comparisons of normally distributed, non-normally distributed and categorical data, respectively. Linear and logistic regression analysis will be used to test whether OSA severity at baseline and follow-up and AT are associated with continuous (e.g. CIMT) and binary (e.g. hypertension) cardiovascular outcomes, respectively, while adjusting for age, gender and body size. Subgroup analysis will also be performed within the AT-treated group to explore factors associated with cardiovascular outcomes after AT. Particularly, the association of pre-AT and follow-up OAHI with various cardiovascular outcomes will be tested. Significance level will be set as 5%. All the analyses will be performed using the statistical software packages SPSS (SPSS Inc., Chicago, Illinois, USA).
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Adenotonsillectomoy +/- turbinate reduction
- Keywords
- obstructive sleep apnea, adenotonsillectomy, cardiovascular
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenotonsillectomoy +/- turbinate reductionProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At a mean of 5 years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start19 Jul 2021
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-Ting AU, PhD, Chinese University of Hong Kong
- Investigators
- Chun Ting Au, PhD, Principal investigator, junau@cuhk.edu.hk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473066
- Sponsor's protocol ID
- HMRF-07181276
- Status last verified
- Feb 2024
- First submitted
- 13 Jul 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified individual participant data that underlie the results in this article (text, tables and figures) will be made available, in addition to study protocol. The data will be made available upon publication to researchers who provide a methodologically sound proposal for individual participant data meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Children With Obstructive Sleep Apnoea Treated With Adenotonsillectomy: Cardiovascular Perspectives
- ClinicalTrials.gov ID
- NCT04473066
- Acronym / sponsor ID
- HMRF-07181276
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, adenotonsillectomy, cardiovascular
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 without surgical treatment and children without OSA. The secondary aim is to explore factors associated with cardiovascular outcomes in subjects with OSA after AT.
We hypothesise that (1) children with OSA underwent AT would have lower cardiovascular risks, namely lower ABP, better cardiac function, lower carotid intima-media thickness (CIMT) and lower carotid arterial stiffness 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.
Study design: A two-centre prospective case-control follow-up study.
Sample size estimation:
We have conducted a pilot study to compare 12 children with residual OSA after AT (defined as post-AT OAHI >=3/h) and 12 age-, sex- and BMI-matched non-snoring controls. The results showed that children with residual OSA had a higher nighttime systolic BP (NSBP) than non-snoring controls (98.9 c.f. 95.6 mm Hg, mean difference = 3.35 mmHg, common SD = 6.54 mmHg, effect size = 0.51). We have a total of 130 subjects with moderate-to-severe OSA who had undergone AT. As the main aim of this study is to assess the treatment effects of AT, we will try to recruit as many AT-treated subjects as possible. Assuming a response rate of 70%, 90 subjects will be recruited. If 45 normal controls were also recruited (case/control ratio = 2:1), the study would provide a power of 87% to detect the difference with a 5% type I error rate. The minimum number of subjects required to detect the difference with an 80% power and a 5% type I error rate are 72 cases and 36 controls if the case/control ratio is 2:1. A sample size of 90 AT-treated subjects will also provide an 80% power to detect the potential effects of pre-AT OAHI and follow-up OAHI on cardiovascular outcomes with medium effect size (assuming a partial R-squared of 0.1), while adjusted for age, sex and BMI in multiple linear regression model within the AT group.
Besides, we have also conducted a separate pilot study comparing a group of 18 children with moderate-to-severe OSA treated with AT and a group of 18 age-, sex- and BMI-matched children with similar OSA severity without AT. The results showed that the nighttime systolic BP in the AT group was reduced by a mean of 2.3 mmHg at a 9-month follow-up visit, whereas the non-AT group had an increase in nighttime systolic BP by a mean of 2.3 mmHg (mean difference = 4.52 mmHg, common SD = 7.34 mmHg, effect size = 0.62). We have a total of 63 candidates for AT who had refused to undergo AT. Assuming a response rate of 70%, 45 subjects will be recruited. A total of 90 cases (AT-treated) and 45 controls (refused AT) provides a power of 95% to detect the expected difference with a type I error rate of 5%. The minimum number of subjects required to detect the difference with an 80% power and a 5% type I error rate are 50 cases and 25 controls if the case/control ratio is 2:1. All sample size and power calculations were done using G*Power (Version 3.1.9.2).
Our target is to recruit a total of 180 subjects, comprising of 90 OSA subjects treated with AT, 45 non-snoring controls and 45 OSA subjects without AT for this follow-up study. We are confident to recruit the target number of subjects as we have been following up the OSA patients regularly in out-patient clinic and we also have a sufficient amount of normal control subjects for matching and recruitment.
Methods:
All participants will have to visit our unit once to undergo anthropometric measurement, overnight polysomnography (PSG), 24-hour ABPM, echocardiographic and arterial assessments. They will be arranged to come to our sleep laboratory at around 9 am in the morning. Twenty-four hour ABPM will be started after resting for 10 minutes upon arrival. Echocardiographic and arterial assessments will be subsequently arranged. They will stay until the next morning after completion of overnight sleep study and 24-h ABPM. For those who are reluctant to complete the whole study protocol, especially for control subjects who may not be willing to stay overnight for the sleep study, their symptoms will be documented by a self- or parent-report questionnaire (appendix 2), and they will have to come to our unit to undergo all the cardiovascular assessments and take the ABP monitor back home and return to us the next day when the 24-h monitoring is completed. Those failed to complete all the outcome assessments will be excluded.
Data processing and analysis:
The AT-treated group will be compared to the refused AT group and the non-snoring controls to assess the between-group differences in various cardiovascular outcomes. Student's t tests, Mann-Whitney U tests and chi-square tests will be used for the comparisons of normally distributed, non-normally distributed and categorical data, respectively. Linear and logistic regression analysis will be used to test whether OSA severity at baseline and follow-up and AT are associated with continuous (e.g. CIMT) and binary (e.g. hypertension) cardiovascular outcomes, respectively, while adjusting for age, gender and body size. Subgroup analysis will also be performed within the AT-treated group to explore factors associated with cardiovascular outcomes after AT. Particularly, the association of pre-AT and follow-up OAHI with various cardiovascular outcomes will be tested. Significance level will be set as 5%. All the analyses will be performed using the statistical software packages SPSS (SPSS Inc., Chicago, Illinois, USA).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adenotonsillectomy (AT) | – | Procedure: Adenotonsillectomoy +/- turbinate reductionChildren 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. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenotonsillectomoy +/- turbinate reductionTonsillectomies 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). | Procedure or surgery | Adenotonsillectomy (AT) |
Primary outcome
24-hour ambulatory blood pressure measurements
Time frame: At a mean of 5 years after intervention
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.
Cardiac function
Time frame: At a mean of 5 years after intervention
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.
Carotid intima-media thickness
Time frame: At a mean of 5 years after intervention
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.
Arterial stiffness
Time frame: At a mean of 5 years after intervention
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided. Deidentified individual participant data that underlie the results in this article (text, tables and figures) will be made available, in addition to study protocol. The data will be made available upon publication to researchers who provide a methodologically sound proposal for individual participant data meta-analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Ting Au, PhD principal investigator
junau@cuhk.edu.hk
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun Ting Au, PhD (+852-35052917, junau@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour ambulatory blood pressure measurements (time frame: At a mean of 5 years after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.