- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06170073
Hong Kong Cohort of Abnormal Sleep in Ageing Population (HK-ASAP): Focusing on Brain Health and Sleep Quality (HK-ASAP)
January 11, 2025 updated by: LU Hanna, Chinese University of Hong Kong
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
238
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tai Po
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Hong Kong, Tai Po, Hong Kong, 100000
- The Chinese University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Healthy normal ageing adults and adults with sleep disturbances.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Poor sleepers
With a total score of Pittsburgh Sleep Quality Index (PSQI) > 5.
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Good sleepers
With a total score of Pittsburgh Sleep Quality Index (PSQI) ≤ 5.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Baseline
|
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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.
|
Baseline
|
|
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.
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Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Memory and learning will be measured by the Word list learning test (WLLT)
Time Frame: Baseline
|
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.
|
Baseline
|
|
Executive functions will be measured by the category verbal fluency test (CVFT)
Time Frame: Baseline
|
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
|
Baseline
|
|
The levels of Aβ40 and Aβ42 will be measured by saliva analysis
Time Frame: Baseline
|
saliva samples will be collected at a consistent time of day to avoid circadian effects and will be kept on ice during the collection.
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Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hanna LU, PhD, Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
January 10, 2025
Study Registration Dates
First Submitted
December 6, 2023
First Submitted That Met QC Criteria
December 6, 2023
First Posted (Actual)
December 14, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 11, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023.496
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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