Remote assessment of sleep apnea and cognitive decline in older adults

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

This study is testing if sleep apnea affects memory and thinking skills in older adults who might be at risk for dementia by monitoring their sleep over a year.

Quick facts

• Study type: Observational
• Enrollment: 750 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05669495 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the relationship between sleep apnea and cognitive decline in older adults at risk for dementia. Using the ANNE Vital Sign System, participants will undergo remote monitoring of their sleep patterns and apnea events over a 12-month period. The study will assess cognitive function at baseline and after one year, while also collecting qualitative feedback on the usability of the monitoring system. The findings could provide insights into the impact of sleep apnea on cognitive health in the aging population.

Who should consider this trial

Good fit: Ideal candidates for this study are older adults aged 60-85 who are cognitively unimpaired or have mild cognitive impairment and are at increased risk for dementia.

Not a fit: Patients who do not meet the age criteria or those who are already diagnosed with advanced dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and management of sleep apnea, potentially slowing cognitive decline in older adults at risk for dementia.

How similar studies have performed: Other studies have suggested a link between sleep apnea and cognitive decline, indicating that this approach may build on existing knowledge rather than being entirely novel.

Eligibility criteria

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

Where this trial is running

Toronto, Ontario

• Sunnybrook Research Institute — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Andrew Centen

Conditions: Alzheimer Disease, Dementia, Mild Cognitive Impairment, Sleep Apnea