Sleep Apnea and Cognition in Older Adults

May 15, 2024 updated by: Dr. Jennifer Rabin, Sunnybrook Health Sciences Centre

Cross-sectional Investigation of Sleep Apnea and Cognition in Older Adults Using the ANNE Vital Sign System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nearly a third of older adults experience difficulty initiating or maintaining sleep and nearly half have sleep apnea. However, current reliance on gold-standard in-lab polysomnography has been a barrier to detecting, quantifying, and measuring these sleep problems. Polysomnography is difficult for many older adults to tolerate, requires specialized technologists to obtain and analyze the recordings, is labour intensive and expensive, and not widely available in many jurisdictions, all of which impede use by primary care clinicians or end-users. Recent advances in wearable sensor development have led to a new generation of wearable sensors that have good potential to overcome these barriers.

Accumulating evidence suggests that poor sleep quality increases the risk of cognitive impairment and dementia, however studies in older adults linking objectively measured sleep function with comprehensive cognitive testing are lacking. The primary objective of this cross-sectional study is to examine the association of several objectively measured sleep parameters (e.g., sleep apnea) with cognitive performance.

The Advanced NeoNatal Epidermal (ANNE) Vital Sign System was created for the purposes of providing real-time vital signs monitoring in the paediatric intensive care unit. 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, to enable accurate measurement of sleep apnea. The characteristics that make the ANNE Vital Sign System ideal for use in children (non-invasive, flexible, ease of use, comfort, skin safety) also make it ideal for use in adults. Compelling in-laboratory preliminary data from our collaborator at Sunnybrook Research Institute (SRI) has demonstrated the capacity for ANNE to detect and characterize sleep apnea in older adults.

After the informed consent process, participants will complete a 1-hour battery of cognitive tests. If participants have completed the same set of cognitive tests in the past year at SRI no cognitive testing will take place.

Following testing, participants will be shown how to affix and remove the sensors to their chest and dominant index finger (or non-dominant if dominant is not available) according to manufacturer recommendations. Participants will be given the device to take home and asked to wear the sensors for a 24-hour period. They will also be provided with ANNE chest adhesive, ANNE limb adhesive, and a clinical waterproof 3M Tegaderm dressing. Participation in the study concludes after the device is worn for the 24-hour period.

Though there are no substantial benefits for participants, this study may lead to a better understanding of the association between sleep apnea and cognition in older adults. Given that poor sleep quality is a risk factor for dementia, there is a need to better characterize the relationship between objective sleep parameters and cognition.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6G3T6
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Jennifer Rabin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy older adults between the ages of 55-85, with 8+ years of education and no frank cognitive impairment or dementia.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Older Adults
  • Age 55-85
  • 8+ years of education
  • No frank cognitive impairment or dementia
Device: 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.
Other Names:
  • ANNE One

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between apnea-hypopnea index and cognitive performance
Time Frame: 24 hours

An apnea-hypopnea index, the combined average number of apneas and hypopneas that occur per hour of sleep, will be calculated from ANNE Vital Sign System data. Study staff will annotate apneas and hypopneas to calculate the index using an EEG annotation tool.

A linear regression model will be constructed to examine the association between apnea-hypopnea index and performance on a battery of neuropsychological tests, which includes:

  1. Montreal Cognitive Assessment
  2. Free and Cued Selective Reminding Test
  3. Benson Complex Figure Copy
  4. Doors Test, Parts A and B
  5. WAIS-III Symbol Digit Coding
  6. Benson Complex Figure Delay
  7. Benson Complex Figure Recognition
  8. 7-24 Spatial Recall Test
  9. Colour Trails Test, parts 1 and 2
  10. Controlled Oral Word Association Test (FAS)
  11. Semantic Fluency (Animals)
  12. Trail Making Test, parts A and B
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Alzheimer Society of Canada

Investigators

  • Principal Investigator: Jennifer Rabin, PhD, Sunnybrook Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2024

Primary Completion (Estimated)

April 1, 2034

Study Completion (Estimated)

April 1, 2034

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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