An observational study in Sleep, Cognition and Aging, sponsored by Sunnybrook Health Sciences Centre. Recruiting at 1 site in Canada. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Sunnybrook Health Sciences Centre · Observational
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.
Nearly a third of older adults experience difficulty initiating or maintaining sleep and nearly half have sleep apnea. However, current reliance on gold-standard in-lab polysomnography has been a barrier to detecting, quantifying, and measuring these sleep problems. Polysomnography is difficult for many older adults to tolerate, requires specialized technologists to obtain and analyze the recordings, is labour intensive and expensive, and not widely available in many jurisdictions, all of which impede use by primary care clinicians or end-users. Recent advances in wearable sensor development have led to a new generation of wearable sensors that have good potential to overcome these barriers.
Accumulating evidence suggests that poor sleep quality increases the risk of cognitive impairment and dementia, however studies in older adults linking objectively measured sleep function with comprehensive cognitive testing are lacking. The primary objective of this cross-sectional study is to examine the association of several objectively measured sleep parameters (e.g., sleep apnea) with cognitive performance.
The Advanced NeoNatal Epidermal (ANNE) Vital Sign System was created for the purposes of providing real-time vital signs monitoring in the paediatric intensive care unit. The ANNE Vital Sign System integrates simultaneous synchronized ambulatory measurement of electrocardiography, photoplethysmography with derived pulse oximetry, pulse arrival time with derived beat-to-beat blood pressure, triaxial accelerometry, respiratory rate, and temperature, to enable accurate measurement of sleep apnea. The characteristics that make the ANNE Vital Sign System ideal for use in children (non-invasive, flexible, ease of use, comfort, skin safety) also make it ideal for use in adults. Compelling in-laboratory preliminary data from our collaborator at Sunnybrook Research Institute (SRI) has demonstrated the capacity for ANNE to detect and characterize sleep apnea in older adults.
After the informed consent process, participants will complete a 1-hour battery of cognitive tests. If participants have completed the same set of cognitive tests in the past year at SRI no cognitive testing will take place.
Following testing, participants will be shown how to affix and remove the sensors to their chest and dominant index finger (or non-dominant if dominant is not available) according to manufacturer recommendations. Participants will be given the device to take home and asked to wear the sensors for a 24-hour period. They will also be provided with ANNE chest adhesive, ANNE limb adhesive, and a clinical waterproof 3M Tegaderm dressing. Participation in the study concludes after the device is worn for the 24-hour period.
Though there are no substantial benefits for participants, this study may lead to a better understanding of the association between sleep apnea and cognition in older adults. Given that poor sleep quality is a risk factor for dementia, there is a need to better characterize the relationship between objective sleep parameters and cognition.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's planned enrollment of 300 is above the median of 109 across 654 observational studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy older adults between the ages of 55-85, with 8+ years of education and no frank cognitive impairment or dementia.
Exclusion Criteria:
* Age 55-85 * 8+ years of education * No frank cognitive impairment or dementia
Device: ANNE Vital Sign System
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
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
Time frame: 24 hours
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Sunnybrook Health Sciences Centre