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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06089096
Enrollment
250
Registered
2023-10-18
Start date
2023-03-07
Completion date
2027-03-31
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment, Obstructive Sleep Apnea, Subjective Cognitive Impairment

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.

Interventions

DIAGNOSTIC_TESTHome Sleep Apnea test (HSAT)

Patient will received HSAT at baseline

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep study parametersBaselineMeasured 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

MeasureTime frameDescription
Sleep apnea symptomsBaselineMeasured 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.
Insomnia symptomsBaselineMeasured 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
Sleep profile and qualityBaselineMeasured 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.
Daytime sleepinessBaselineMeasured 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
Activities of Daily LivingBaselineMeasured 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.
Cognitive functionBaselineMeasured 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.
Ability to inhibit cognitive interferenceBaselineMeasured 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.
Depression symptomsBaselineMeasured by Geriatric Depression Scale - short form. The score ranges from 0 to 15. The higher the scores the more severe of depression.

Countries

Hong Kong

Contacts

Primary ContactSau Man Mary Ip, MD
msmip@hku.hk2255 5885
Backup ContactYuen Kwan Agnes Lai, PhD
ayklai@hkmu.edu.hk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026