Recruiting

Observational Study

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05669495

Conditions

Alzheimer Disease

Dementia

Mild Cognitive Impairment

Sleep Apnea

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

ANNE Vital Sign System

Study Details

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

Study ID

NCT05669495

Start date

Nov 10, 2022

Status verified date

Dec, 2022

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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:

1. Ages 60-85
2. Sufficient proficiency in English or French
3. Technical ability to participate in remote assessments
4. 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)
5. 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

Exclusion Criteria:

1. Known nickel allergy
2. Known cardiac implantable device
3. Known arrhythmias
4. Otherwise unable to use the sensors; for example, finger amputations

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

1. Participants who, in the opinion of the investigator, are not able to complete trial procedures remotely or adhere to the schedule of study assessments.
2. Individuals where English or French is not sufficiently proficient for remote clinical assessment.
3. 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.
4. Individuals who have a clinical diagnosis of Dementia
5. Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of >1 or having a diagnosis of dementia based on DSM-IV criteria
6. Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) <13

Study Design

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

ANNE Vital Sign System

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.

Primary outcome measure

  • Apnea Hypopnea Index [ Time Frame: Baseline ]
  • Apnea Hypopnea Index [ Time Frame: 12-months ]
  • Oxygen Desaturation Index [ Time Frame: Baseline ]
  • Oxygen Desaturation Index [ Time Frame: 12-months ]
  • Hypoxemia Burden [ Time Frame: Baseline ]
  • Hypoxemia Burden [ Time Frame: 12-months ]
  • Time with oxygen saturation below 90% (O2<90) [ Time Frame: Baseline ]
  • Time with oxygen saturation below 90% (O2<90) [ Time Frame: 12-months ]

Central Contacts and Locations

Central contacts

Andrew Centen

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

Locations

Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada, M4N3M5

Principal Investigator:

Andrew Lim

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jan 3, 2023

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-01-03.