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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06089096
Other study ID # UW 23-072
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 7, 2023
Est. completion date June 30, 2025

Study information

Verified date October 2023
Source The University of Hong Kong
Contact Sau Man Mary Ip, MD
Phone 2255 4605
Email msmip@hku.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date June 30, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Hong Kong Queen Mary Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

Emamian F, Khazaie H, Tahmasian M, Leschziner GD, Morrell MJ, Hsiung GY, Rosenzweig I, Sepehry AA. The Association Between Obstructive Sleep Apnea and Alzheimer's Disease: A Meta-Analysis Perspective. Front Aging Neurosci. 2016 Apr 12;8:78. doi: 10.3389/fnagi.2016.00078. eCollection 2016. — View Citation

Leng Y, McEvoy CT, Allen IE, Yaffe K. Association of Sleep-Disordered Breathing With Cognitive Function and Risk of Cognitive Impairment: A Systematic Review and Meta-analysis. JAMA Neurol. 2017 Oct 1;74(10):1237-1245. doi: 10.1001/jamaneurol.2017.2180. Erratum In: JAMA Neurol. 2018 Jan 1;75(1):133. — View Citation

Musiek ES, Ju YS. Targeting Sleep and Circadian Function in the Prevention of Alzheimer Disease. JAMA Neurol. 2022 Sep 1;79(9):835-836. doi: 10.1001/jamaneurol.2022.1732. No abstract available. — View Citation

Yaffe K, Laffan AM, Harrison SL, Redline S, Spira AP, Ensrud KE, Ancoli-Israel S, Stone KL. Sleep-disordered breathing, hypoxia, and risk of mild cognitive impairment and dementia in older women. JAMA. 2011 Aug 10;306(6):613-9. doi: 10.1001/jama.2011.1115. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep study parameters 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. Baseline
Secondary Daytime sleepiness 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 Baseline
Secondary Sleep apnea symptoms 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. Baseline
Secondary Insomnia symptoms 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 Baseline
Secondary Sleep profile and quality 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. Baseline
Secondary Depression symptoms Measured by Geriatric Depression Scale - short form. The score ranges from 0 to 15. The higher the scores the more severe of depression. Baseline
Secondary Activities of Daily Living 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.
Baseline
Secondary Cognitive function 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. Baseline
Secondary Ability to inhibit cognitive interference 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. Baseline
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