Obstructive Sleep ApneaNCT04658290
Prevalence of Obstructive Sleep Apnea (OSA) and the Association With Cognitive Impairment
An observational study of Obstructive Sleep Apnea and Cognitive Impairment, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The study is aimed to carry out an epidemiology study investigating the prevalence of obstructive sleep apnea (OSA) and the association with cognitive impairment. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Cognitive Impairment
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Aug 2020to 28 Aug 2026
- 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 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive subjects are recruited from the Brain Health Longitudinal Study which was launched in July 2019. Up to 5000 subjects aged 40-74 years without a confirmed brain disorder. Participants will be assigned to undergo a portable at-home sleep study which records the airflow, heart rate, body position and oxygen saturation.
Who may be able to join
- Have stability of at least 4 weeks on permitted medications (i.e. medications known not to affect sleep architecture or circadian rhythms).
Who cannot join
- Suspected dementia or a score of <24 on the mini-mental state examination
- A diagnosis of neurological disorders (e.g. Parkinson's Disease, Epilepsy, Multiple Sclerosis)
- Psychiatric disorders including current major depression; bipolar disorder; schizophrenia
- Other known clinically significant sleep disorders (e.g. narcolepsy)
- Been currently receiving CPAP or bi-level pressure for OSA
Trial locations and contacts
1 site in 1 country.
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
The study is aimed to carry out an epidemiology study investigating the prevalence of obstructive sleep apnea (OSA) and the association with cognitive impairment.
- Conditions
- Obstructive Sleep Apnea, Cognitive Impairment
- Medical subject headings
- Sleep Apnea, Obstructive, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects having apnea-hypopnea index of more than 5
Measured: 1 year
Secondary outcomes (2)
incidence of cerebrovascular disease
Measured: 5 years
Montreal Cognitive Assessment
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 posted8 Dec 2020
- Study start29 Aug 2020
- Primary completion28 Aug 2026 (estimated)
- Study completion28 Aug 2026 (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
- 500 participants (estimated)
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
- NCT04658290
- Sponsor's protocol ID
- SleepBrain_2019
- Status last verified
- Feb 2024
- First submitted
- 31 Aug 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Prevalence of Obstructive Sleep Apnea (OSA) and the Association With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04658290
- Acronym / sponsor ID
- SleepBrain_2019
- Conditions
- Obstructive Sleep Apnea, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 29 Aug 2020 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 8 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.
The study is aimed to carry out an epidemiology study investigating the prevalence of obstructive sleep apnea (OSA) and the association with cognitive impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive subjects are recruited from the Brain Health Longitudinal Study which was launched in July 2019. Up to 5000 subjects aged 40-74 years without a confirmed brain disorder. Participants will be assigned to undergo a portable at-home sleep study which records the airflow, heart rate, body position and oxygen saturation.
Key inclusion criteria (1 listed)
- Have stability of at least 4 weeks on permitted medications (i.e. medications known not to affect sleep architecture or circadian rhythms).
Key exclusion criteria (5 listed)
- Suspected dementia or a score of <24 on the mini-mental state examination
- A diagnosis of neurological disorders (e.g. Parkinson's Disease, Epilepsy, Multiple Sclerosis)
- Psychiatric disorders including current major depression; bipolar disorder; schizophrenia
- Other known clinically significant sleep disorders (e.g. narcolepsy)
- Been currently receiving CPAP or bi-level pressure for OSA
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
Number of subjects having apnea-hypopnea index of more than 5
Time frame: 1 year
2 secondary outcomes
incidence of cerebrovascular disease
Time frame: 5 years
Montreal Cognitive Assessment
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
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 and Cognitive Impairment, 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 1 inclusion and 5 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: status not confirmed, 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?
Results are not available in the source record.
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?
Number of subjects having apnea-hypopnea index of more than 5 (time frame: 1 year). 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.