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.
Study 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.
Eligibility
Sex
ALL
Min age
55 Years
Max age
85 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Sufficient knowledge of English to understand and provide informed consent
2. Competent to provide consent
3. Aged 55-85, Male and Female
4. ≥ 8 years of education
5. Capable of cooperating for the duration of the study procedures and assessments
6. No frank cognitive impairment or dementia
7. Sufficient (corrected) vision to participate in cognitive testing
8. Sufficient (corrected) hearing to participate in cognitive testing
Exclusion Criteria:
1. Cannot read and comprehend English language instructions
2. Major cardio- or cerebro-vascular event (heart attack, stroke, significant white matter changes)
3. Unstable diseases (e.g., pulmonary, endocrine disorder)
4. Active malignancy or infectious diseases
5. History of significant learning disability
6. Major psychiatric/neurologic/degenerative disorder, including a diagnosis of mild cognitive impairment or dementia
7. History of significant head trauma or recurrent concussions requiring hospitalization followed by persistent neurologic defaults or known structural brain abnormalities
8. Pain or sleep disorder that could interfere with cognitive testing
9. Major medical concerns that might interfere with cognitive testing
10. Recent history of substance/drug abuse
11. Known nickel allergy
12. Known cardiac implantable device
13. Known arrhythmias
14. Outside the included age range
15. Pregnant or breast feeding
16. Otherwise unable to use the ANNE sensors; for example, finger amputations.
Primary outcome measure(s)
Association between apnea-hypopnea index and cognitive performance — 24 hours 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
Trial sites (1)
Facility
City
Region
Status
Sunnybrook Health Sciences Centre
Toronto
Ontario
Recruiting
More Sunnybrook Health Sciences Centre trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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