NCT06170073

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

December 6, 2023

Last Update Submit

January 11, 2025

Conditions

Keywords

AgeingSleep disturbancesCognitionBrain healthLongevity

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Memory and learning will be measured by the Word list learning test (WLLT)

    Baseline

  • Executive functions will be measured by the category verbal fluency test (CVFT)

    Baseline

  • The levels of Aβ40 and Aβ42 will be measured by saliva analysis

    Baseline

Study Arms (2)

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.

Eligibility Criteria

Age55 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy normal ageing adults and adults with sleep disturbances.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Tai Po District, 100000, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Participant's saliva will be collected for further analysis.

MeSH Terms

Conditions

ParasomniasCognitive DysfunctionBrain Diseases

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersCognition DisordersNeurocognitive DisordersCentral Nervous System Diseases

Study Officials

  • Hanna LU, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

October 1, 2023

Primary Completion

December 31, 2024

Study Completion

January 10, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01

Locations