Clinical trial NCT06089096: Sleep Apnea and Cognitive Function in Subjects With Subjective or Mild Cognitive Impairment
Official title: Exploring the Association of Sleep Apnea With Cognitive Function in Subjects With Subjective or Mild Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Mild Cognitive Impairment
Subjective Cognitive Impairment
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cross-sectional study aims to recruit subjects with mild or subjective cognitive impairment in Queen Mary Hospital, Hong Kong.

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.

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

Primary outcomes:
measure: Sleep study parameters
timeFrame: Baseline
Secondary outcomes:
measure: Daytime sleepiness
timeFrame: Baseline
measure: Sleep apnea symptoms
timeFrame: Baseline
measure: Insomnia symptoms
timeFrame: Baseline
measure: Sleep profile and quality
timeFrame: Baseline
measure: Depression symptoms
timeFrame: Baseline
measure: Activities of Daily Living
timeFrame: Baseline
measure: Cognitive function
timeFrame: Baseline
measure: Ability to inhibit cognitive interference
timeFrame: Baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: School of Clinical Medicine, The University of Hong Kong
name: Sau Man Mary Ip, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.