EpidemiologyNCT05077748
An 18-year Follow-up Study on OSA in a Population-based Cohort
An observational study of Epidemiology and Natural History, run by Chinese University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Epidemiology, Natural History, Obstructive Sleep Apnea
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2021to 30 Sep 2025
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Subjects participants from the 2003 cohort
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An 18-year Follow-up Study on Obstructive Sleep Apnoea in a Population-based Cohort
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.
Read the 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.
- Conditions
- Epidemiology, Natural History, Obstructive Sleep Apnea, Cardiovascular Complication, Neurocognitive Dysfunction
- Keywords
- Obstructive sleep apnea, Sleep disordered breathing, Hypertension, Cardiovascular complication, Neurocognitive dysfunction
- Medical subject headings
- Sleep Apnea, Obstructive, Cognition Disorders, Sleep Apnea Syndromes, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
OSA status at 18-year follow-up visit
OSA status of the participants at the 18-year follow-up visit
Measured: Through study completion, an average of 2 years
Secondary outcomes (4)
Factors associated with the persistence or the development of OSA in adulthood
Factors associated with the persistence or the development of OSA in adulthood
Measured: Through study completion, an average of 2 years
Ambulatory blood pressure parameters at 18-year follow-up visit
Ambulatory blood pressure parameters as measures of long-term cardiovascular participants of children who had OSA compared to those without OSA
Measured: Through study completion, an average of 2 years
Echocardiographic parameters at 18-year follow-up visit
Echocardiographic parameters as measures of long-term cardiovascular outcomes of participants who had OSA compared to those without OSA
Measured: Through study completion, an average of 2 years
Neurocognitive function at 18-year follow-up visit
Neurocognitive function outcomes as measures of long-term neurocognitive outcomes of participants who had OSA compared to those without OSA
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start20 Oct 2021
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpidemiologyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Kate Ching Ching Chan, Chinese University of Hong Kong
- Investigators
- Ching Ching, Kate Dr. CHAN, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077748
- Sponsor's protocol ID
- FUOSA 3.1
- Status last verified
- Dec 2025
- First submitted
- 2 Oct 2021
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available at this moment.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 18-year Follow-up Study on Obstructive Sleep Apnoea in a Population-based Cohort
- ClinicalTrials.gov ID
- NCT05077748
- Acronym / sponsor ID
- FUOSA 3.1
- Conditions
- Epidemiology, Natural History, Obstructive Sleep Apnea, Cardiovascular Complication, Neurocognitive Dysfunction
- Keywords
- Obstructive sleep apnea, Sleep disordered breathing, Hypertension, Cardiovascular complication, Neurocognitive dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 14 Oct 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Subjects participants from the 2003 cohort
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Other | – |
Primary outcome
OSA status at 18-year follow-up visit
Time frame: Through study completion, an average of 2 years
OSA status of the participants at the 18-year follow-up visit
4 secondary outcomes
Factors associated with the persistence or the development of OSA in adulthood
Time frame: Through study completion, an average of 2 years
Ambulatory blood pressure parameters at 18-year follow-up visit
Time frame: Through study completion, an average of 2 years
Echocardiographic parameters at 18-year follow-up visit
Time frame: Through study completion, an average of 2 years
Neurocognitive function at 18-year follow-up visit
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available at this moment.
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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.
Ching Ching, Kate Dr. CHAN study director
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidemiology and Natural History, run by Chinese University of Hong Kong at 1 site in China.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSA status at 18-year follow-up visit (time frame: Through study completion, an average of 2 years). 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 15 Dec 2025.