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Clinical Trial Summary

Our research team has established a polysomnography (PSG) quantified population-based paediatric sleep cohort in 2003 for a childhood OSA prevalence study. Subjects were recruited from 13 randomly selected primary schools. All subjects from this original cohort will be invited to join this 18-year follow-up study to repeat the following data collection: questionnaires, anthropometric measurement, sleep study, 24-hour ambulatory blood pressure (ABP) measurement, echocardiography and neurocognitive assessment.


Clinical Trial Description

Our research team has established a polysomnography (PSG) quantified population-based paediatric sleep cohort in 2003 for a childhood OSA prevalence study. Subjects were recruited from 13 randomly selected primary schools. In each school, two randomly chosen classes from each grade were invited to participate. In the first phase, all parents of children in the randomly selected schools were invited to attend an education forum during which full explanation of the purpose and flow of the study was given. An envelope containing a validated parent proxy OSAS screening questionnaire and consent was then distributed to parents within a week after the forum. From our previous research, a composite symptom score (summation of the scores of these three questions) of 7 or more has 75.4% sensitivity and 80.5% specificity, compared with polysomnography, to detect OSAS among children aged 5-15 years who had attended our paediatric clinics. Children with a composite symptom score of less than 7 were assigned a computer-generated random number and were invited as a control group with a ratio of 1:2 in the second phase. All children belonging to the high risk of OSAS group and the randomly selected subjects at low risk of OSAS were invited to participate the baseline epidemiological study. In total 619 children aged 5-13 years underwent detailed assessments including anthropometric measurements, airway examination, ambulatory blood pressure recording and overnight PSG. 67 children had moderate-to-severe OSA (obstructive apnoea hypopnoea index, OAHI ≥5/h), 199 had mild OSA (OAHI 1 to <5/h), 103 were primary snorers (OAHI <1/h but snore ≥3 nights per week in the past 12 months) and 250 were normal controls (OAHI <1/h and snore <3 nights per week in the past 12 months).(1) All subjects from this original cohort will be invited to join this 18-year follow-up study to repeat the following data collection: questionnaires, anthropometric measurement, sleep study, 24-hour ambulatory blood pressure (ABP) measurement, echocardiography and neurocognitive assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05077748
Study type Observational
Source Chinese University of Hong Kong
Contact WEI GUO
Phone (852)9068 3708
Email guowei@link.cuhk.edu.hk
Status Recruiting
Phase
Start date October 20, 2021
Completion date September 30, 2025

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