Recruiting

Observational Study

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06423118

Conditions

Sleep

Cognition

Aging

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Interventions

ANNE Vital Sign System

Study Details

Brief 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.

Conditions

Sleep

Cognition

Aging

Study ID

NCT06423118

Start date

Apr 9, 2024

Status verified date

Apr, 2024

Completion date

Apr, 2034

Anticipated

Primary completion date

Apr, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Older Adults

  • Age 55-85
  • 8+ years of education
  • No frank cognitive impairment or dementia

Interventions

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.

Primary outcome measure

  • Association between apnea-hypopnea index and cognitive performance [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M6G3T6

Contacts

Principal Investigator:

Jennifer Rabin, PhD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

May 21, 2024

Last verified

Apr, 2024

Keywords

  • sleep
  • cognition
  • aging

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 2024-05-21.