Sleep DisturbanceHK-ASAPNCT06170073
Hong Kong Cohort of Abnormal Sleep in Ageing Population (HK-ASAP): Focusing on Brain Health and Sleep Quality
An observational study of Sleep Disturbance and Aging, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Poor sleep quality can significantly jeopardize the brain health, cognitive functions, daily activities, quality of life, and even be implicated as a key potential contributing factor in the development of accelerated cognitive decline and prodromal dementia. Read more about this study
- Who is it for?
- Ages 55 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Aging, Cognitive Decline
- How many people
- 238 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2023to 10 Jan 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 55 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy normal ageing adults and adults with sleep disturbances.
Who may be able to join
- Chinese old adults are the ones who are over 60 years of chronological age.
- Sleep disturbance: individual's subjective sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI) with a total score >5.
Who cannot join
- History of bipolar disorders or psychosis.
- History of major neurological deficits, including stroke, transient ischemic attack or brain tumor.
- Unable to participant magnetic resonance imaging (MRI) scanning.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong
Hong Kong, Tai Po District, 100000
About this study
Official title: Hong Kong Cohort of Abnormal Sleep in Ageing Population (HK-ASAP): an Observational Study on Brain Health and Sleep Quality in Community-dwelling Older Adults
Poor sleep quality can significantly jeopardize the brain health, cognitive functions, daily activities, quality of life, and even be implicated as a key potential contributing factor in the development of accelerated cognitive decline and prodromal dementia. Consequently, research efforts to understand, and therefore potentially model, the effects of sleep quality on cognition and brain health are of great pragmatic values.
Read the detailed description
Objectives: This study aims to investigate the cognitive changes in older adults with sleep disturbances, examine the neuroimaging contributors to poor sleep quality and cognitive deficits.
- Conditions
- Sleep Disturbance, Aging, Cognitive Decline, Brain Disease
- Keywords
- Ageing, Sleep disturbances, Cognition, Brain health, Longevity
- Medical subject headings
- Parasomnias, Cognitive Dysfunction, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Poor sleepers | With a total score of Pittsburgh Sleep Quality Index (PSQI) > 5. | |
| Good sleepers | With a total score of Pittsburgh Sleep Quality Index (PSQI) ≤ 5. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) is a validated 19-item self-reported questionnaire
Measured: Baseline
Global cognition will be measured by the Montreal Cognitive Assessment Hong Kong version (HK MoCA)
The Montreal Cognitive Assessment Hong Kong version (HK MoCA) is a validated and widely used screening assessment for detecting cognitive impairment, which measures an array of cognitive functions such as visuospatial, memory, language and attention.
Measured: Baseline
Complex attention will be measured by the Attention Network Test (ANT)
The ANT paradigm, as a computerized test, was used and performed by E-Prime 3.0.
Measured: Baseline
Secondary outcomes (3)
Memory and learning will be measured by the Word list learning test (WLLT)
Word list learning test (WLLT), consisting of fifteen semantically non-associated words that is presented consecutively over three free trials of immediate recall, a 20-min delayed recall and followed by yes/no recognition.
Measured: Baseline
Executive functions will be measured by the category verbal fluency test (CVFT)
On each trial of CVFT, the participants will be asked to overtly generate words in the animal category, fruit category and vegetable category as many as possible within 60 seconds
Measured: Baseline
The levels of Aβ40 and Aβ42 will be measured by saliva analysis
saliva samples will be collected at a consistent time of day to avoid circadian effects and will be kept on ice during the collection.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Oct 2023
- Primary completion31 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, LU Hanna, Chinese University of Hong Kong
- Investigators
- Hanna LU, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170073
- Sponsor's protocol ID
- 2023.496
- Acronym
- HK-ASAP
- Status last verified
- Jan 2025
- First submitted
- 6 Dec 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ni X, Yang NS, Yuen YS, Gong Y, Li Z, Hu X, Yuan Y, Lu H. HK-ASAP study: protocol for a prospective cohort study on sleep quality, brain reserve and cognitive phenotypes in community-dwelling older adults. BMC Geriatr. 2026 Mar 25;26(1):625. doi: 10.1186/s12877-026-07367-0.
PubMed 41882580
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hong Kong Cohort of Abnormal Sleep in Ageing Population (HK-ASAP): an Observational Study on Brain Health and Sleep Quality in Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT06170073
- Acronym / sponsor ID
- HK-ASAP / 2023.496
- Conditions
- Sleep Disturbance, Aging, Cognitive Decline, Brain Disease
- Keywords
- Ageing, Sleep disturbances, Cognition, Brain health, Longevity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 14 Dec 2023 (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.
Poor sleep quality can significantly jeopardize the brain health, cognitive functions, daily activities, quality of life, and even be implicated as a key potential contributing factor in the development of accelerated cognitive decline and prodromal dementia. Consequently, research efforts to understand, and therefore potentially model, the effects of sleep quality on cognition and brain health are of great pragmatic values.
Detailed description
Objectives: This study aims to investigate the cognitive changes in older adults with sleep disturbances, examine the neuroimaging contributors to poor sleep quality and cognitive deficits.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poor sleepers | – | –With a total score of Pittsburgh Sleep Quality Index (PSQI) > 5. |
| Good sleepers | – | –With a total score of Pittsburgh Sleep Quality Index (PSQI) ≤ 5. |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy normal ageing adults and adults with sleep disturbances.
Key inclusion criteria (2 listed)
- Chinese old adults are the ones who are over 60 years of chronological age.
- Sleep disturbance: individual's subjective sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI) with a total score >5.
Key exclusion criteria (3 listed)
- History of bipolar disorders or psychosis.
- History of major neurological deficits, including stroke, transient ischemic attack or brain tumor.
- Unable to participant magnetic resonance imaging (MRI) scanning.
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
Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI) is a validated 19-item self-reported questionnaire
Global cognition will be measured by the Montreal Cognitive Assessment Hong Kong version (HK MoCA)
Time frame: Baseline
The Montreal Cognitive Assessment Hong Kong version (HK MoCA) is a validated and widely used screening assessment for detecting cognitive impairment, which measures an array of cognitive functions such as visuospatial, memory, language and attention.
Complex attention will be measured by the Attention Network Test (ANT)
Time frame: Baseline
The ANT paradigm, as a computerized test, was used and performed by E-Prime 3.0.
3 secondary outcomes
Memory and learning will be measured by the Word list learning test (WLLT)
Time frame: Baseline
Executive functions will be measured by the category verbal fluency test (CVFT)
Time frame: Baseline
The levels of Aβ40 and Aβ42 will be measured by saliva analysis
Time frame: Baseline
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 14 Jan 2025.
- Derived from this study: PubMed 41882580Ni X, Yang NS, Yuen YS, Gong Y, Li Z, Hu X, Yuan Y, Lu H. HK-ASAP study: protocol for a prospective cohort study on sleep quality, brain reserve and cognitive phenotypes in community-dwelling older adults. BMC Geriatr. 2026 Mar 25;26(1):625. doi: 10.1186/s12877-026-07367-0.
- Individual participant dataSharing planned: Undecided
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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.
Hanna LU, PhD principal investigator
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 Sleep Disturbance and Aging, 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 2 inclusion and 3 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 14 Jan 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 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?
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?
Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06170073, which also lists 1 linked publication.
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 14 Jan 2025.