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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06170073
Other study ID # 2023.496
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date March 31, 2025

Study information

Verified date December 2023
Source Chinese University of Hong Kong
Contact Hanna LU, PhD
Phone 28314305
Email hannalu@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Consequently, research efforts to understand, and therefore potentially model, the effects of sleep quality on cognition and brain health are of great pragmatic values.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 244
Est. completion date March 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 95 Years
Eligibility 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 de?cits, including stroke, transient ischemic attack or brain tumor. - Unable to participant magnetic resonance imaging (MRI) scanning.

Study Design


Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong Tai Po

Sponsors (2)

Lead Sponsor Collaborator
Chinese University of Hong Kong The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline
Primary 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. Baseline
Primary 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. Baseline
Secondary 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. Baseline
Secondary 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 Baseline
Secondary The levels of Aß40 and Aß42 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. Baseline
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