NCT05077748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

October 2, 2021

Last Update Submit

December 8, 2025

Conditions

Keywords

Obstructive sleep apneaSleep disordered breathingHypertensionCardiovascular complicationNeurocognitive dysfunction

Outcome Measures

Primary Outcomes (1)

  • OSA status at 18-year follow-up visit

    OSA status of the participants at the 18-year follow-up visit

    Through study completion, an average of 2 years

Secondary Outcomes (4)

  • Factors associated with the persistence or the development of OSA in adulthood

    Through study completion, an average of 2 years

  • Ambulatory blood pressure parameters at 18-year follow-up visit

    Through study completion, an average of 2 years

  • Echocardiographic parameters at 18-year follow-up visit

    Through study completion, an average of 2 years

  • Neurocognitive function at 18-year follow-up visit

    Through study completion, an average of 2 years

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • \- Subjects participants from the 2003 cohort

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, 999077, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting blood samples will be taken from participants with venipuncture. The sample will be sent for biochemical measurements including lipid profile (Total cholesterol, total glycerides, high-density lipoprotein-cholesterol, low-density lipoprotein cholesterol) and serum glucose in the University Pathology Service. Plasma will also be collected in EDTA anticoagulant tubes, pre-processed and frozen at -80 degree Celsius for future analysis. Because of budget limitation, further blood test analysis is not included in the current proposal.

MeSH Terms

Conditions

Sleep Apnea, ObstructiveCognition DisordersSleep Apnea SyndromesHypertension

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesNeurocognitive DisordersMental DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Ching Ching, Kate Dr. CHAN

    Chinese University of Hong Kong

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professional Consultant, Department of Paediatrics

Study Record Dates

First Submitted

October 2, 2021

First Posted

October 14, 2021

Study Start

October 20, 2021

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available at this moment.

Locations