Remote Sleep Assessment in Adults at Risk for Dementia Using the ANNE Vital Sign System

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Sleep apnea is characterized by temporary pauses or stops to participant's breathing. Currently, sleep apnea is diagnosed using an in-lab sleep study, which involves spending a night in a sleep laboratory hooked up to wires on the head, chest, and legs. However, this is not feasible for many older adults. To overcome this barrier, the investigators will utilize an investigational vital signs monitor - the Advanced NeoNatal Epidermal (ANNE) Vital Sign System (Sibel Health, Evanston, IL,USA). The primary objective of this study is to test the hypothesis that sleep apnea is associated with accelerated cognitive decline in older adults at risk for dementia. The investigators will measure sleep apnea at baseline and 12 months later and relate this to cognitive function at the same time points. Sex-stratification will be used in analyses as appropriate. Qualitative feedback forms will be used to collect information about participant ease of use and experience with the ANNE Vital Sign System.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: t
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• The only inclusion criteria for this study is that participants must have consented and enrolled into a CTU affiliated study. There are no additional inclusion criteria. Individuals from CTU affiliated studies will be asked to confirm their enrollment in a CTU affiliated study as part of the informed consent process for this study.

• For reference, inclusion criteria of CTU affiliated studies from which we will recruit may include, but are not limited to, the following list:

⁃ Ages 60-85

⁃ Sufficient proficiency in English or French

⁃ Technical ability to participate in remote assessments

⁃ Meets criteria for No Dementia and one of the following (according to CCNA Criteria):

∙ Cognitively Unimpaired

‣ Cognitively Unimpaired plus Subjective Cognitive Impairment

‣ Mild Cognitive Impairment (MCI)

⁃ AND Classified as being at increased risk of dementia based on at least one of the following: a. First-degree family history of dementia b. Self-Reported or documented current and/or history at midlife (45-60 years) of the following risk factors: i. Hypertension ii. Hypercholesterolemia iii. Body Mass Index \> 30 kg/m2 iv. Physical Inactivity v. Insomnia vi. Vascular-metabolic risk

Locations
Other Locations
Canada
Sunnybrook Research Institute
RECRUITING
Toronto
Contact Information
Primary
Andrew Centen
andrew.centen@sunnybrook.ca
416-480-5143
Time Frame
Start Date: 2022-11-10
Estimated Completion Date: 2025-10
Participants
Target number of participants: 750
Treatments
No dementia, increased risk of dementia
Meets criteria for No Dementia and one of the following (according to CCNA Criteria):~1. Cognitively Unimpaired~2. Cognitively Unimpaired plus Subjective Cognitive Impairment~3. Mild Cognitive Impairment (MCI)~AND Classified as being at increased risk of dementia based on at least one of the following:~1. First-degree family history of dementia~2. Self-Reported or documented current and/or history at midlife (45-60 years) of the following risk factors:~i. Hypertension ii. Hypercholesterolemia iii. Body Mass Index \> 30 kg/m2 iv. Physical Inactivity v. Insomnia vi. Vascular-metabolic risk
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre
Collaborators: Canadian Consortium on Neurodegeneration in Aging

This content was sourced from clinicaltrials.gov