Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423118
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
Sleep Apnea and Cognition in Older Adults
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Cross-sectional Investigation of Sleep Apnea and Cognition in Older Adults Using the ANNE Vital Sign System
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None