Clinical trial NCT05077748: An 18-year Follow-up Study on OSA in a Population-based Cohort
Official title: An 18-year Follow-up Study on Obstructive Sleep Apnoea in a Population-based Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epidemiology
Natural History
Obstructive Sleep Apnea
Cardiovascular Complication
Neurocognitive Dysfunction
Keywords: Obstructive sleep apnea
Sleep disordered breathing
Hypertension
Cardiovascular complication
Neurocognitive dysfunction
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
First posted: 2021-10-14
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In our current proposal, subjects from the 2003 cohort will be invited to join this follow-up study. Written consent will be obtained from the participants. The study protocol will be conducted in compliance with the Declaration of Helsinki. Ethics approval will be obtained from the Clinical Research Ethics Committee of the Joint Chinese University of Hong Kong - New Territories East Cluster.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

- Subjects participants from the 2003 cohort

Exclusion Criteria:

* Neuromuscular disease
* Pathological central apnoea
* Severe chronic lung disease with documented hypoxaemia or awake oxygen saturation \<92%
* Chronic respiratory failure (unrelated to OSA)
* Acquired upper airway disease/obstruction
* Craniofacial abnormalities (e.g. secondary to trauma and malignancy)

Other arrangement:

* Subjects who have any respiratory illness within 2 weeks of the scheduled follow-up visit will have their assessment re-arranged until they have fully recovered.
* Subjects taking medications that may affect sleep, upper airway patency or blood pressure (for example sedatives, stimulants, antihistamines, and cough medicine) within a week from recruitment will also be rescheduled to participate when they are free from medication use for at least 2 weeks.
* Subjects with hypertension and are on anti-hypertensive therapy are allowed to continue on their medication and the information will be obtained and recorded during data collection.

Primary outcomes:
measure: OSA status at 18-year follow-up visit
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Factors associated with the persistence or the development of OSA in adulthood
timeFrame: Through study completion, an average of 2 years
measure: Ambulatory blood pressure parameters at 18-year follow-up visit
timeFrame: Through study completion, an average of 2 years
measure: Echocardiographic parameters at 18-year follow-up visit
timeFrame: Through study completion, an average of 2 years
measure: Neurocognitive function at 18-year follow-up visit
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Department of Paediatrics, The Chinese University of Hong Kong
name: Ching Ching, Kate Dr. CHAN
role: STUDY_DIRECTOR
References: