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

NCT06089096 | Recruiting

• 1 other identifier: UW 23-072
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Mild Cognitive Impairment; Subjective Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Sleep study parameters

  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.

  Baseline

Secondary Outcomes (8)

• Daytime sleepiness

  Baseline

• Sleep apnea symptoms

  Baseline

• Insomnia symptoms

  Baseline

• Sleep profile and quality

  Baseline

• Depression symptoms

  Baseline

Study Arms (1)

MCI or SCI patient

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

Diagnostic Test: Home Sleep Apnea test (HSAT)

Interventions

Home Sleep Apnea test (HSAT) DIAGNOSTIC_TEST

Patient will received HSAT at baseline

MCI or SCI patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sau Man Mary Ip, MD

  School of Clinical Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sau Man Mary Ip, MD

CONTACT

2255 5885; msmip@hku.hk

Yuen Kwan Agnes Lai, PhD

CONTACT

ayklai@hkmu.edu.hk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Professor

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: March 7, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

HK (1)