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Clinical Trials/NCT06089096
NCT06089096
Recruiting
Not Applicable

Exploring the Association of Sleep Apnea With Cognitive Function in Subjects With Subjective or Mild Cognitive Impairment

The University of Hong Kong1 site in 1 country250 target enrollmentMarch 7, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
The University of Hong Kong
Enrollment
250
Locations
1
Primary Endpoint
Sleep study parameters
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2023
End Date
March 31, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Professor Mary Ip Sau-man

Honorary Clinical Professor

The University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Aged 18 years and above
  • 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,
  • 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
  • Able to speak and read Chinese
  • Adequate visual and auditory to perform a cognitive test

Exclusion Criteria

  • Diagnosed psychiatric illness with or without medication, e.g. major depressive disorder.
  • 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.
  • Diagnosis of major unstable illness or cancer on active treatment
  • Unable to perform Home Sleep Apnea Test
  • Those patients who require legal guardians

Outcomes

Primary Outcomes

Sleep study parameters

Time Frame: 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 Outcomes

  • Daytime sleepiness(Baseline)
  • Insomnia symptoms(Baseline)
  • Depression symptoms(Baseline)
  • Activities of Daily Living(Baseline)
  • Sleep profile and quality(Baseline)
  • Cognitive function(Baseline)
  • Ability to inhibit cognitive interference(Baseline)
  • Sleep apnea symptoms(Baseline)

Study Sites (1)

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