Obstructive Sleep ApneaNCT04659291
Prospective Study on Patients With Obstructive Sleep Apnea in Hong Kong (PrOSA)
An observational study of Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Obstructive sleep apnea syndrome (OSAS) is a common disorder with prevalence rates of at least 4% among the middle-aged male Caucasians and Hong Kong (HK) Chinese populations. It is characterized by repetitive episodes of upper airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 1,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Aug 2020to 29 Aug 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients are recruited from the Respiratory Clinic at the Prince of Wales Hospital with clinical suspicion of sleep-disordered breathing. The Respiratory Clinic receives referral from hospital specialists and general practitioners. The clinical evaluation procedure includes an interview by a respiratory specialist followed by either an inpatient polysomnography or home polygraphic study according to the patients' clinical characteristics and preference in concordance of the guidelines from the American Academy of Sleep Medicine (AASM). Sleep records will be scored based on standardized criteria of AASM.
Who may be able to join
- suspected obstructive sleep apnea syndrome
- aged 18 or above
- must be able to speak, read and understand Chinese or English
- possess the ability to respond to questions and follow instructions.
Who cannot join
- already treated sleep apnea,
- a limited life expectancy due to illness unrelated to sleep apnea
- human immunodeficiency virus (HIV),
- advanced renal disease,
- uncontrolled malignancies
- documented alcohol or drug abuse up to 1 year prior to inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong
Hong Kong, Please Select
Susanna SS Ng, MBChB, (852) 35053493, ssng@cuhk.edu.hk
About this study
Obstructive sleep apnea syndrome (OSAS) is a common disorder with prevalence rates of at least 4% among the middle-aged male Caucasians and Hong Kong (HK) Chinese populations. It is characterized by repetitive episodes of upper airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor health status. OSAS patients are at increased risks of non-fatal and fatal cardiovascular morbidity and mortality including sudden death, in addition to being more prone to road traffic accidents. However, there is no long term follow up of patients with OSAS on the incidence of cardiovascular disease, compliance on the therapy and the impact of the quality of life. The study is aimed to carry out a prospective observational study assessing the role of OSAS as a possible cause of increased cardiovascular risk and cognitive decline.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- cognitive function
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of Cardiovascular disease
Measured: 5 years
Secondary outcomes (2)
Change of Montreal Cognitive Assessment score (MoCA)
MoCA scores range between 0 and 30. Higher scores mean a better cognitive function.
Measured: 5 years
Change of Epworth Sleepiness Score
The Epworth Sleepiness Scale can be used to assess daytime sleepiness. The scores range between 0 and 24. Higher scores mean more sleepiness.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start30 Aug 2020
- Primary completion29 Aug 2028 (estimated)
- Study completion29 Aug 2028 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanna SS Ng, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659291
- Sponsor's protocol ID
- PrOSA study/2020
- Status last verified
- Feb 2024
- First submitted
- 31 Aug 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Patients With Obstructive Sleep Apnea in Hong Kong (PrOSA)
- ClinicalTrials.gov ID
- NCT04659291
- Acronym / sponsor ID
- PrOSA study/2020
- Conditions
- Obstructive Sleep Apnea
- Keywords
- cognitive function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 29 Aug 2028 (estimated)
- Study completion
- 29 Aug 2028 (estimated)
- First posted
- 9 Dec 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.
Obstructive sleep apnea syndrome (OSAS) is a common disorder with prevalence rates of at least 4% among the middle-aged male Caucasians and Hong Kong (HK) Chinese populations. It is characterized by repetitive episodes of upper airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor health status. OSAS patients are at increased risks of non-fatal and fatal cardiovascular morbidity and mortality including sudden death, in addition to being more prone to road traffic accidents. However, there is no long term follow up of patients with OSAS on the incidence of cardiovascular disease, compliance on the therapy and the impact of the quality of life. The study is aimed to carry out a prospective observational study assessing the role of OSAS as a possible cause of increased cardiovascular risk and cognitive decline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients are recruited from the Respiratory Clinic at the Prince of Wales Hospital with clinical suspicion of sleep-disordered breathing. The Respiratory Clinic receives referral from hospital specialists and general practitioners. The clinical evaluation procedure includes an interview by a respiratory specialist followed by either an inpatient polysomnography or home polygraphic study according to the patients' clinical characteristics and preference in concordance of the guidelines from the American Academy of Sleep Medicine (AASM). Sleep records will be scored based on standardized criteria of AASM.
Key inclusion criteria (4 listed)
- suspected obstructive sleep apnea syndrome
- aged 18 or above
- must be able to speak, read and understand Chinese or English
- possess the ability to respond to questions and follow instructions.
Key exclusion criteria (6 listed)
- already treated sleep apnea,
- a limited life expectancy due to illness unrelated to sleep apnea
- human immunodeficiency virus (HIV),
- advanced renal disease,
- uncontrolled malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of Cardiovascular disease
Time frame: 5 years
2 secondary outcomes
Change of Montreal Cognitive Assessment score (MoCA)
Time frame: 5 years
Change of Epworth Sleepiness Score
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
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 Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of Cardiovascular disease (time frame: 5 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 20 Feb 2024.