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NCT Number: NCT06423118

Sleep Apnea and Cognition in Older Adults

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.

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Key information

Conditions

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M6G3T6, Canada

Location status: Recruiting

Location contact

Jennifer Rabin, PhD

PRINCIPAL_INVESTIGATOR

Silina Boshmaf, BSc

CONTACT

[email protected]

416-480-6100

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sufficient knowledge of English to understand and provide informed consent
  • Competent to provide consent
  • Aged 55-85, Male and Female
  • ≥ 8 years of education
  • Capable of cooperating for the duration of the study procedures and assessments
  • No frank cognitive impairment or dementia
  • Sufficient (corrected) vision to participate in cognitive testing
  • Sufficient (corrected) hearing to participate in cognitive testing

Exclusion criteria

  • Cannot read and comprehend English language instructions
  • Major cardio- or cerebro-vascular event (heart attack, stroke, significant white matter changes)
  • Unstable diseases (e.g., pulmonary, endocrine disorder)
  • Active malignancy or infectious diseases
  • History of significant learning disability
  • Major psychiatric/neurologic/degenerative disorder, including a diagnosis of mild cognitive impairment or dementia
  • History of significant head trauma or recurrent concussions requiring hospitalization followed by persistent neurologic defaults or known structural brain abnormalities
  • Pain or sleep disorder that could interfere with cognitive testing
  • Major medical concerns that might interfere with cognitive testing
  • Recent history of substance/drug abuse
  • Known nickel allergy
  • Known cardiac implantable device
  • Known arrhythmias
  • Outside the included age range
  • Pregnant or breast feeding
  • Otherwise unable to use the ANNE sensors; for example, finger amputations.

Treatment and study plan

ANNE Vital Sign System

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.

Other names: ANNE One

Primary outcomes

  1. 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:

    • Montreal Cognitive Assessment
    • Free and Cued Selective Reminding Test
    • Benson Complex Figure Copy
    • Doors Test, Parts A and B
    • WAIS-III Symbol Digit Coding
    • Benson Complex Figure Delay
    • Benson Complex Figure Recognition
    • 7-24 Spatial Recall Test
    • Colour Trails Test, parts 1 and 2
    • Controlled Oral Word Association Test (FAS)
    • Semantic Fluency (Animals)
    • Trail Making Test, parts A and B

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Nyman, BSc

CONTACT

[email protected]

416-480-6100

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Alzheimer Society of Canada

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
May 21, 2024
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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