Sleep Apnea and Cognition in Older Adults

NCT ID: NCT06423118

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-09
• Study Completion Date: 2034-04-30

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.

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.

Conditions

Sleep; Cognition; Aging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy Older Adults

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

ANNE Vital Sign System

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Other Intervention Names

ANNE One

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alzheimer Society of Canada

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Jennifer Rabin

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Rabin, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Research Institute

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Alexander Nyman, BSc

Role: CONTACT

alexander.nyman@sri.utoronto.ca

416-480-6100

Facility Contacts

Silina Boshmaf, BSc

Role: primary

silina.boshmaf@sri.utoronto.ca

416-480-6100

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

5140

Identifier Type: -

Identifier Source: org_study_id