SleepNCT06423118
Sleep Apnea and Cognition in Older Adults
An observational study of Sleep and Cognition, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- What is being tested?
- ANNE Vital Sign System
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 9 Apr 2024to Apr 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy older adults between the ages of 55-85, with 8+ years of education and no frank cognitive impairment or dementia.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M6G3T6
Silina Boshmaf, BSc, 416-480-6100, silina.boshmaf@sri.utoronto.ca
Jennifer Rabin, PhD
About this study
Official title: 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?
Read more
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.
Read the 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.
- Being tested
- ANNE Vital Sign System
- Keywords
- sleep, cognition, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANNE Vital Sign SystemDevice
Also called ANNE One
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Older Adults | * Age 55-85
* 8+ years of education
* No frank cognitive impairment or dementia Receives: Device: ANNE Vital Sign System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between apnea-hypopnea index and cognitive performance
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start9 Apr 2024
- Primary completionApr 2034 (estimated)
- Study completionApr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer Society of Canada
- Responsible party
- Principal investigator, Dr. Jennifer Rabin, Sunnybrook Health Sciences Centre
- Investigators
- Jennifer Rabin, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423118
- Sponsor's protocol ID
- 5140
- Status last verified
- Apr 2024
- First submitted
- 15 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. doi: 10.1093/sleep/18.6.425.
PubMed 7481413Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.
PubMed 27568340Oosterman JM, van Someren EJ, Vogels RL, Van Harten B, Scherder EJ. Fragmentation of the rest-activity rhythm correlates with age-related cognitive deficits. J Sleep Res. 2009 Mar;18(1):129-35. doi: 10.1111/j.1365-2869.2008.00704.x.
PubMed 19250179Shi L, Chen SJ, Ma MY, Bao YP, Han Y, Wang YM, Shi J, Vitiello MV, Lu L. Sleep disturbances increase the risk of dementia: A systematic review and meta-analysis. Sleep Med Rev. 2018 Aug;40:4-16. doi: 10.1016/j.smrv.2017.06.010. Epub 2017 Jul 6.
PubMed 28890168Sindi S, Kareholt I, Johansson L, Skoog J, Sjoberg L, Wang HX, Johansson B, Fratiglioni L, Soininen H, Solomon A, Skoog I, Kivipelto M. Sleep disturbances and dementia risk: A multicenter study. Alzheimers Dement. 2018 Oct;14(10):1235-1242. doi: 10.1016/j.jalz.2018.05.012. Epub 2018 Jul 17.
PubMed 30030112Zhu X, Zhao Y. Sleep-disordered breathing and the risk of cognitive decline: a meta-analysis of 19,940 participants. Sleep Breath. 2018 Mar;22(1):165-173. doi: 10.1007/s11325-017-1562-x. Epub 2017 Sep 13.
PubMed 28905231Chung HU, Kim BH, Lee JY, Lee J, Xie Z, Ibler EM, Lee K, Banks A, Jeong JY, Kim J, Ogle C, Grande D, Yu Y, Jang H, Assem P, Ryu D, Kwak JW, Namkoong M, Park JB, Lee Y, Kim DH, Ryu A, Jeong J, You K, Ji B, Liu Z, Huo Q, Feng X, Deng Y, Xu Y, Jang KI, Kim J, Zhang Y, Ghaffari R, Rand CM, Schau M, Hamvas A, Weese-Mayer DE, Huang Y, Lee SM, Lee CH, Shanbhag NR, Paller AS, Xu S, Rogers JA. Binodal, wireless epidermal electronic systems with in-sensor analytics for neonatal intensive care. Science. 2019 Mar 1;363(6430):eaau0780. doi: 10.1126/science.aau0780.
PubMed 30819934
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Investigation of Sleep Apnea and Cognition in Older Adults Using the ANNE Vital Sign System
- ClinicalTrials.gov ID
- NCT06423118
- Acronym / sponsor ID
- 5140
- Keywords
- sleep, cognition, aging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Alzheimer Society of Canada
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- Apr 2034 (estimated)
- Study completion
- Apr 2034 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Older Adults | – | Device: ANNE Vital Sign System* Age 55-85 * 8+ years of education * No frank cognitive impairment or dementia |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy older adults between the ages of 55-85, with 8+ years of education and no frank cognitive impairment or dementia.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANNE Vital Sign SystemAlso: ANNE OneThe ANNE Vital Sign System is a pair of non-invasive, flexible sensors originally designed for vital signs monitoring in the paediatric intensive care unit. | Device | Healthy Older Adults |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 7481413Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. doi: 10.1093/sleep/18.6.425.
- Background: PubMed 27568340Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.
- Background: PubMed 19250179Oosterman JM, van Someren EJ, Vogels RL, Van Harten B, Scherder EJ. Fragmentation of the rest-activity rhythm correlates with age-related cognitive deficits. J Sleep Res. 2009 Mar;18(1):129-35. doi: 10.1111/j.1365-2869.2008.00704.x.
- Background: PubMed 28890168Shi L, Chen SJ, Ma MY, Bao YP, Han Y, Wang YM, Shi J, Vitiello MV, Lu L. Sleep disturbances increase the risk of dementia: A systematic review and meta-analysis. Sleep Med Rev. 2018 Aug;40:4-16. doi: 10.1016/j.smrv.2017.06.010. Epub 2017 Jul 6.
- Background: PubMed 30030112Sindi S, Kareholt I, Johansson L, Skoog J, Sjoberg L, Wang HX, Johansson B, Fratiglioni L, Soininen H, Solomon A, Skoog I, Kivipelto M. Sleep disturbances and dementia risk: A multicenter study. Alzheimers Dement. 2018 Oct;14(10):1235-1242. doi: 10.1016/j.jalz.2018.05.012. Epub 2018 Jul 17.
- Background: PubMed 28905231Zhu X, Zhao Y. Sleep-disordered breathing and the risk of cognitive decline: a meta-analysis of 19,940 participants. Sleep Breath. 2018 Mar;22(1):165-173. doi: 10.1007/s11325-017-1562-x. Epub 2017 Sep 13.
- Background: PubMed 30819934Chung HU, Kim BH, Lee JY, Lee J, Xie Z, Ibler EM, Lee K, Banks A, Jeong JY, Kim J, Ogle C, Grande D, Yu Y, Jang H, Assem P, Ryu D, Kwak JW, Namkoong M, Park JB, Lee Y, Kim DH, Ryu A, Jeong J, You K, Ji B, Liu Z, Huo Q, Feng X, Deng Y, Xu Y, Jang KI, Kim J, Zhang Y, Ghaffari R, Rand CM, Schau M, Hamvas A, Weese-Mayer DE, Huang Y, Lee SM, Lee CH, Shanbhag NR, Paller AS, Xu S, Rogers JA. Binodal, wireless epidermal electronic systems with in-sensor analytics for neonatal intensive care. Science. 2019 Mar 1;363(6430):eaau0780. doi: 10.1126/science.aau0780.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Rabin, PhD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Cognition, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Nyman, BSc (416-480-6100, alexander.nyman@sri.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between apnea-hypopnea index and cognitive performance (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06423118, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.