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NCT Number: NCT06089096

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Cognition Disorders Cognitive Dysfunction Dyssomnias Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Subjective Cognitive Impairment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Sleep Apnea test (HSAT)

Diagnostic Test

Patient will received HSAT at baseline

Primary outcomes

  1. 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

  1. Daytime sleepiness

    Time frame: Baseline

    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

  2. Sleep apnea symptoms

    Time frame: Baseline

    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.

  3. Insomnia symptoms

    Time frame: Baseline

    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

  4. Sleep profile and quality

    Time frame: Baseline

    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.

  5. Depression symptoms

    Time frame: Baseline

    Measured by Geriatric Depression Scale - short form. The score ranges from 0 to 15. The higher the scores the more severe of depression.

  6. Activities of Daily Living

    Time frame: Baseline

    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.

  7. Cognitive function

    Time frame: Baseline

    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.

  8. Ability to inhibit cognitive interference

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sau Man Mary Ip, MD

CONTACT

[email protected]

2255 5885

Yuen Kwan Agnes Lai, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 18, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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