Sleep Apnea and Cognitive Function in Subjects With Subjective or Mild Cognitive Impairment

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT06089096
Collaborator
(none)
400
1
27.8
14.4

Study Details

Study Description

Brief Summary

Obstructive sleep apnea (OSA) is recurrent episodes of partial or complete obstruction of the upper airway during sleep that causes intermittent hypoxia and sleep fragmentation and leads to cardiometabolic and neurocognitive sequelae. Chronic intermittent hypoxia, sleep fragmentation of OSA, and insufficient sleep have been significantly associated with higher risks of neurocognitive impairment, including mild cognitive impairment (MCI) and Alzheimer's disease. Thus, sleep and circadian function might be modifiable neurocognitive impairment factors.

The significance of the study is to understand the relationships of MCI with sleep apnea and sleep-related symptoms, which helps pave the groundwork for further research.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Home Sleep Apnea test (HSAT)

Detailed Description

Obstructive sleep apnea (OSA) is recurrent episodes of partial or complete obstruction of the upper airway during sleep that causes intermittent hypoxia and sleep fragmentation. Chronic intermittent hypoxia, sleep fragmentation of OSA, and insufficient sleep have been significantly associated with higher risks of neurocognitive impairment, including mild cognitive impairment (MCI) and Alzheimer's disease. Thus, sleep and circadian function might be modifiable neurocognitive impairment factors.

A recent review of 11 studies involving 5826 subjects [96% with OSA and 9% with MCI or Alzheimer's disease] suggests OSA is a modifiable risk factor for cognitive decline. Thus, improving sleep, sleep apnea and circadian function could be a high-value intervention target to alleviate cognitive impairment and decline in subjects with MCI.

The study aims to understand the relationships of prevalent sleep apnea and sleep-related symptoms with neurocognitive status in patients who presented with the main complaint of neurocognitive impairment ( to the Memory clinic). The information would help pave the groundwork for further research.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Exploring the Association of Sleep Apnea With Cognitive Function in Subjects With Subjective or Mild Cognitive Impairment
Actual Study Start Date :
Mar 7, 2023
Anticipated Primary Completion Date :
Feb 28, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
MCI or SCI patient

At baseline: Cognitive tests, questionnaire, and Home Sleep Apnea Test will be done.

Diagnostic Test: Home Sleep Apnea test (HSAT)
Patient will received HSAT at baseline

Outcome Measures

Primary Outcome Measures

  1. Sleep study parameters [Baseline]

    Measured by Apnea Hypopnea Index (AHI). Score less than 5 is no OSA, score 5-15 is categorized as mild OSA, 15-30 is categorized as moderate OSA, and>30 is severe OSA.

Secondary Outcome Measures

  1. Daytime sleepiness [Baseline]

    Measured by Epworth Sleepiness Scale. Each item asks the individual to rate their daytime sleepiness. The total score ranges from 0 to 24. The higher the scores, the greater the severity of daytime sleepiness

  2. Sleep apnea symptoms [Baseline]

    Measured by Pittsburgh Sleep Quality Index. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21, with the higher total score indicating worse sleep quality.

  3. Insomnia symptoms [Baseline]

    Measured by Severe Insomnia Index. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 28. The higher the scores the greater the severity of insomnia

  4. Sleep profile and quality [Baseline]

    Measured by Pittsburgh Sleep Quality Index. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21, with the higher total score indicating worse sleep quality.

  5. Depression symptoms [Baseline]

    Measured by Geriatric Depression Scale - short form. The score ranges from 0 to 15. The higher the scores the more severe of depression.

  6. Activities of Daily Living [Baseline]

    Measured by Instrumental Activities of Daily Living Scale (I.A.D.L.) and Simplified Barthel ADL index. The total score of I.A.D.L ranges from 0 to 8, "0" is the worst possible score, while "8" is the best possible score. The total score of A.D.L ranges from 0 to 20, "0" is the worst possible score, while "20" is the best possible score.

  7. Cognitive function [Baseline]

    Measured by Montreal Cognitive Assessment (MoCA) score and ADAS-Cog. The scores of MoCA range from 0 to 30, "0" is the worst possible score and "30" is the best possible score. The scores of ADAS-Cog range from 0 to 70, "0" is the best possible score and "70" is the worst possible score.

  8. Ability to inhibit cognitive interference [Baseline]

    Measured by Stroop Colour and Word Test (SCWT). Scored by time and error. A longer time indicates a worst score, while a shorter time indicates a better score.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

(i) Aged 18 years and above (ii) Clinical diagnosis of mild cognitive impairment (MCI) based on Petersen's criteria. The criteria include the following: (1) memory problems, (2) objective memory disorder, (3) absence of other cognitive disorders or repercussions on daily life, (4) normal general cognitive function and (5) absence of dementia OR, (iii) Diagnosis of subjective cognitive impairment, based on the subject's own complaint of cognitive impairment but with an unremarkable assessment of the Hong Kong version of Montreal Cognitive Assessment scores (iv) Able to speak and read Chinese (v) Adequate visual and auditory to perform a cognitive test

Exclusion Criteria:

(i) Diagnosed psychiatric illness with or without medication, e.g. major depressive disorder.

(ii) Other clear organic causes of cognitive impairment, e.g. old stroke, brain tumour, dementia with Lewy body, Parkinson's disease, normal pressure hydrocephalus, neurosyphilis, autoimmune encephalitis, substance abuse, history of alcohol abuse.

(iii) Diagnosis of major unstable illness or cancer on active treatment (iv) Unable to perform Home Sleep Apnea Test (v) Those patients who require legal guardians

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Mary Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Sau Man Mary Ip, MD, School of Clinical Medicine, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Professor Mary Ip Sau-man, Honorary Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT06089096
Other Study ID Numbers:
  • UW 23-072
First Posted:
Oct 18, 2023
Last Update Posted:
Oct 18, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2023