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Recruiting NCT06089096

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

Observational Obstructive Sleep Apnea Mild Cognitive Impairment Subjective Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home Sleep Apnea test (HSAT).
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Mild Cognitive Impairment, Subjective Cognitive Impairment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • Sleep study parameters [Time frame: Baseline]
Secondary outcome measures (8)
  • Daytime sleepiness [Time frame: Baseline]
  • Sleep apnea symptoms [Time frame: Baseline]
  • Insomnia symptoms [Time frame: Baseline]
  • Sleep profile and quality [Time frame: Baseline]
  • Depression symptoms [Time frame: Baseline]
  • Activities of Daily Living [Time frame: Baseline]
  • Cognitive function [Time frame: Baseline]
  • Ability to inhibit cognitive interference [Time frame: Baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Hong Kong · 1 center
  • Queen Mary Hospital — Hong Kong

Publications

  • 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. PMID 21828324
  • 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. PMID 27148046
  • 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. PMID 28846764
  • 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. PMID 35816332

Identifiers

NCT: NCT06089096 · UW 23-072

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗