ANNE Vital Sign System Remote Sleep Assessment

NCT05669495 | Unknown

• 1 other identifier: 5366
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Dementia; Mild Cognitive Impairment; Sleep Apnea

Outcome Measures

Primary Outcomes (8)

• Apnea Hypopnea Index

  Number of times per hour breathing slows or stops

  Baseline

• Apnea Hypopnea Index

  Number of times per hour breathing slows or stops

  12-months

• Oxygen Desaturation Index

  Number of times per hour oxygen dips 4% or more

  Baseline

• Oxygen Desaturation Index

  Number of times per hour oxygen dips 4% or more

  12-months

• Hypoxemia Burden

  integral area under the desaturation curve

  Baseline

• Hypoxemia Burden

  integral area under the desaturation curve

  12-months

• Time with oxygen saturation below 90% (O2<90)

  As described in title

  Baseline

• Time with oxygen saturation below 90% (O2<90)

  As described in title

  12-months

Secondary Outcomes (8)

• Sex-stratification on Apnea Hypopnea Index

  Baseline

• Sex-stratification on Apnea Hypopnea Index

  12-months

• Sex-stratification on Oxygen Desaturation Index

  Baseline

• Sex-stratification on Oxygen Desaturation Index

  12-months

• Sex-stratification on Hypoxemia Burden

  Baseline

Study Arms (1)

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

Device: ANNE Vital Sign System

Interventions

ANNE Vital Sign System DEVICE

The ANNE Vital Sign System is a wireless remote monitoring system consisting of two flexible, soft, and skin-mounted electronic devices for use by researchers and healthcare professionals for continuous collection of physiological data in home and professional healthcare settings. 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, which would enable accurate measurement of sleep apnea. Indeed, in compelling in-laboratory preliminary data, we show the capacity for the ANNE Vital Sign System to detect and characterize sleep apnea in older patients. The ANNE Vital Sign System is non-invasive, flexible, easy to use, comfortable, and skin safe.

No dementia, increased risk of dementia

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Enrolled participants in the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CTU) and affiliated trials. All participants will be individuals ages 60-85 classified as Not Dementia according to Canadian Consortium for Neurodegeneration in Aging (CCNA) criteria and classified as being at increased risk of dementia.

You may qualify if:

• 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

You may not qualify if:

• Known nickel allergy
• Known cardiac implantable device
• Known arrhythmias
• Otherwise unable to use the sensors; for example, finger amputations
• Participants who, in the opinion of the investigator, are not able to complete trial procedures remotely or adhere to the schedule of study assessments.
• Individuals where English or French is not sufficiently proficient for remote clinical assessment.
• Individuals who do not have the technical ability. Technical ability is defined as having computer and internet access; ability to send and receive emails; ability to participate in remote assessments.
• Individuals who have a clinical diagnosis of Dementia
• Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of \>1 or having a diagnosis of dementia based on DSM-IV criteria
• Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) \<13

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Consortium on Neurodegeneration in Aging: collaborator

Study Sites (1)

Sunnybrook Research Institute

Toronto, Ontario, M4N3M5, Canada

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Central Study Contacts

Andrew Centen

CONTACT

416-480-5143; andrew.centen@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: January 3, 2023
• Study Start: November 10, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: January 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Duration of study

Locations

CA (1)