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

NCT ID: NCT06089096

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-07

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea Mild Cognitive Impairment Subjective Cognitive Impairment

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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MCI or SCI patient

At baseline: Cognitive tests, questionnaire, and Home Sleep Apnea Test will be done.

Home Sleep Apnea test (HSAT)

Intervention Type DIAGNOSTIC_TEST

Patient will received HSAT at baseline

Interventions

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Home Sleep Apnea test (HSAT)

Patient will received HSAT at baseline

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor Mary Ip Sau-man

Honorary Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sau Man Mary Ip, MD

Role: PRINCIPAL_INVESTIGATOR

School of Clinical Medicine, The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Sau Man Mary Ip, MD

Role: CONTACT

2255 5885

Yuen Kwan Agnes Lai, PhD

Role: CONTACT

Facility Contacts

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Sau Man Mary Ip, MD

Role: primary

2255 5885

Yuen Kwan Agnes Lai, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 21828324 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27148046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28846764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35816332 (View on PubMed)

Other Identifiers

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UW 23-072

Identifier Type: -

Identifier Source: org_study_id

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