Sleep Apnea and Cognition in Older Adults

NCT06423118 | Recruiting FDA Device

• 1 other identifier: 5140
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this cross-sectional, observational, medical device trial is to examine the association of several sleep parameters, including specific respiratory events and an apnea-hypopnea index, with cognitive performance in older adults. The main question the study aims to answer is: Is there an association between sleep parameters with cognitive performance? Researchers will collect sleep parameters from participants using a device called the ANNE Vital Sign System and will test whether they are associated with performance on different memory and thinking tasks. Participants will: Complete a battery of cognitive tests to assess their memory and thinking performance. Wear the ANNE Vital Sign System continuously for a period of 24 hours.

Conditions

Sleep; Cognition; Aging

Keywords

sleep; cognition; aging

Outcome Measures

Primary Outcomes (1)

• Association between apnea-hypopnea index and cognitive performance

  An apnea-hypopnea index, the combined average number of apneas and hypopneas that occur per hour of sleep, will be calculated from ANNE Vital Sign System data. Study staff will annotate apneas and hypopneas to calculate the index using an EEG annotation tool. A linear regression model will be constructed to examine the association between apnea-hypopnea index and performance on a battery of neuropsychological tests, which includes: 1. Montreal Cognitive Assessment 2. Free and Cued Selective Reminding Test 3. Benson Complex Figure Copy 4. Doors Test, Parts A and B 5. WAIS-III Symbol Digit Coding 6. Benson Complex Figure Delay 7. Benson Complex Figure Recognition 8. 7-24 Spatial Recall Test 9. Colour Trails Test, parts 1 and 2 10. Controlled Oral Word Association Test (FAS) 11. Semantic Fluency (Animals) 12. Trail Making Test, parts A and B

  24 hours

Study Arms (1)

Healthy Older Adults

* Age 55-85 * 8+ years of education * No frank cognitive impairment or dementia

Device: ANNE Vital Sign System

Interventions

ANNE Vital Sign System DEVICE

The ANNE Vital Sign System is a pair of non-invasive, flexible sensors originally designed for vital signs monitoring in the paediatric intensive care unit.

Also known as: ANNE One

Healthy Older Adults

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy older adults between the ages of 55-85, with 8+ years of education and no frank cognitive impairment or dementia.

You may qualify if:

• Sufficient knowledge of English to understand and provide informed consent
• Competent to provide consent
• Aged 55-85, Male and Female
• ≥ 8 years of education
• Capable of cooperating for the duration of the study procedures and assessments
• No frank cognitive impairment or dementia
• Sufficient (corrected) vision to participate in cognitive testing
• Sufficient (corrected) hearing to participate in cognitive testing

You may not qualify if:

• Cannot read and comprehend English language instructions
• Major cardio- or cerebro-vascular event (heart attack, stroke, significant white matter changes)
• Unstable diseases (e.g., pulmonary, endocrine disorder)
• Active malignancy or infectious diseases
• History of significant learning disability
• Major psychiatric/neurologic/degenerative disorder, including a diagnosis of mild cognitive impairment or dementia
• History of significant head trauma or recurrent concussions requiring hospitalization followed by persistent neurologic defaults or known structural brain abnormalities
• Pain or sleep disorder that could interfere with cognitive testing
• Major medical concerns that might interfere with cognitive testing
• Recent history of substance/drug abuse
• Known nickel allergy
• Known cardiac implantable device
• Known arrhythmias
• Outside the included age range
• Pregnant or breast feeding

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Alzheimer Society of Canada: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M6G3T6, Canada

RECRUITING

Related Publications (7)

• Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. doi: 10.1093/sleep/18.6.425.

  PMID: 7481413 BACKGROUND

• Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.

  PMID: 27568340 BACKGROUND

• Oosterman JM, van Someren EJ, Vogels RL, Van Harten B, Scherder EJ. Fragmentation of the rest-activity rhythm correlates with age-related cognitive deficits. J Sleep Res. 2009 Mar;18(1):129-35. doi: 10.1111/j.1365-2869.2008.00704.x.

  PMID: 19250179 BACKGROUND

• Shi L, Chen SJ, Ma MY, Bao YP, Han Y, Wang YM, Shi J, Vitiello MV, Lu L. Sleep disturbances increase the risk of dementia: A systematic review and meta-analysis. Sleep Med Rev. 2018 Aug;40:4-16. doi: 10.1016/j.smrv.2017.06.010. Epub 2017 Jul 6.

  PMID: 28890168 BACKGROUND

• Sindi S, Kareholt I, Johansson L, Skoog J, Sjoberg L, Wang HX, Johansson B, Fratiglioni L, Soininen H, Solomon A, Skoog I, Kivipelto M. Sleep disturbances and dementia risk: A multicenter study. Alzheimers Dement. 2018 Oct;14(10):1235-1242. doi: 10.1016/j.jalz.2018.05.012. Epub 2018 Jul 17.

  PMID: 30030112 BACKGROUND

• Zhu X, Zhao Y. Sleep-disordered breathing and the risk of cognitive decline: a meta-analysis of 19,940 participants. Sleep Breath. 2018 Mar;22(1):165-173. doi: 10.1007/s11325-017-1562-x. Epub 2017 Sep 13.

  PMID: 28905231 BACKGROUND

• Chung HU, Kim BH, Lee JY, Lee J, Xie Z, Ibler EM, Lee K, Banks A, Jeong JY, Kim J, Ogle C, Grande D, Yu Y, Jang H, Assem P, Ryu D, Kwak JW, Namkoong M, Park JB, Lee Y, Kim DH, Ryu A, Jeong J, You K, Ji B, Liu Z, Huo Q, Feng X, Deng Y, Xu Y, Jang KI, Kim J, Zhang Y, Ghaffari R, Rand CM, Schau M, Hamvas A, Weese-Mayer DE, Huang Y, Lee SM, Lee CH, Shanbhag NR, Paller AS, Xu S, Rogers JA. Binodal, wireless epidermal electronic systems with in-sensor analytics for neonatal intensive care. Science. 2019 Mar 1;363(6430):eaau0780. doi: 10.1126/science.aau0780.

  PMID: 30819934 BACKGROUND

Study Officials

• Jennifer Rabin, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Nyman, BSc

CONTACT

416-480-6100; alexander.nyman@sri.utoronto.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): April 1, 2034
• Study Completion (Estimated): April 1, 2034
• Last Updated: May 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)