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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089096
• Other study ID #: UW 23-072
• Status: Recruiting
• Start date: March 7, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: The University of Hong Kong
• Contact: Sau Man Mary Ip, MD
• Phone: 2255 4605
• Email: msmip[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

(i) Aged 18 years and above (ii) 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, (iii) 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 (iv) Able to speak and read Chinese (v) Adequate visual and auditory to perform a cognitive test Exclusion Criteria: (i) Diagnosed psychiatric illness with or without medication, e.g. major depressive disorder. (ii) 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. (iii) Diagnosis of major unstable illness or cancer on active treatment (iv) Unable to perform Home Sleep Apnea Test (v) Those patients who require legal guardians

Related Conditions & MeSH terms

• Apnea
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Subjective Cognitive Impairment

Intervention

Diagnostic Test:
• Home Sleep Apnea test (HSAT)
Patient will received HSAT at baseline

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

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. — View 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. Erratum In: JAMA Neurol. 2018 Jan 1;75(1):133. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Daytime sleepiness	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	Baseline
Secondary	Sleep apnea symptoms	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.	Baseline
Secondary	Insomnia symptoms	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	Baseline
Secondary	Sleep profile and quality	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.	Baseline
Secondary	Depression symptoms	Measured by Geriatric Depression Scale - short form. The score ranges from 0 to 15. The higher the scores the more severe of depression.	Baseline
Secondary	Activities of Daily Living	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.	Baseline
Secondary	Cognitive function	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.	Baseline
Secondary	Ability to inhibit cognitive interference	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.	Baseline