Sleep DisturbanceNCT04400617
Sleep Quality in Assisted-Living Residents
An observational study of Sleep Disturbance and Aging, run by University of Calgary at 1 site in Canada.
Trial summary
Assisted living residents who have sleep disturbances are at great risk of developing cognitive impairments. The identification of factors that increase sleep problems in this population is the first step towards improving sleep disorders and reducing and/or delaying the occurrence of cognitive impairments in this… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sleep Disturbance, Aging
- What is being tested?
- Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2023to 31 Dec 2027
- 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 50 years and older
- All sexes
- Adult, Older adult
Study population: The target population will be inactive men and women residents of the Brenda Strafford Foundation (> 50 yrs. old).
Who may be able to join
- Be inactivity, which will be defined as an engagement in < 3 sessions/week of 20 min or more of vigorous exercise;
- Be able to move independently without the assistance of a wheelchair.
Who cannot join
- Diagnosis of a developmental handicap;
- Residents who are not able to understand communication and be understood by others and do not have decision-making capacity according to the Cognitive Performance Scale (CPS) > 3; The investigators will assess all the resident's capacity with the Brenda Strafford Foundation caregivers, even if their CPS is within the range included in the study (CPS 0-3);
- Terminal illness (life expectancy < 1 year);
- Not fluent in English;
- Currently participating in another trial;
- Comorbid medical or neurological illnesses (e.g., multiple sclerosis) that would confound cognitive assessments or make trial completion unlikely (in the site investigator's opinion);
- Contraindication for the tests.
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
University of Calgary
Calgary, Alberta, T2N 4N1
About this study
Official title: Understanding the Association Between Sleep Quality, Physical Activity, and Memory in Assisted-Living Residents
Assisted living residents who have sleep disturbances are at great risk of developing cognitive impairments. The identification of factors that increase sleep problems in this population is the first step towards improving sleep disorders and reducing and/or delaying the occurrence of cognitive impairments in this population. Physical activity has been proposed to improve sleep quality in older individuals, but there is currently no scientific evidence of how sleep mediates the relationship between physical activity and cognition in assisted living residents. This is a cross-sectional study that investigates the relationship between sleep quality, functional/physical capacity, and cognitive performance. Participants will be recruited through a non-probabilistic sampling method (convenience) as this is a feasibility study that aims to identify, for the first time, sleep disorders in assisted living residents using objective measures of sleep. Sleep quality will be measured with polysomnography, actigraphy, and questionnaire. Functional and physical capacity will be assessed through walking tasks and actigraphy. Cognitive tasks will be used to assess memory. This study will bring new insights into the factors that affect the quality of life and sleep in assisted living residents. The evidence-based knowledge acquired on-site will be translated and shared with the local and global scientific community to raise awareness of the factors that contribute to increasing institutionalization and dependent living. Results obtained from objective and subjective measures of sleep will be of great importance to develop specialized clinical expertise and behavioral interventions that will meet residents' needs.
Read the detailed description
Specific Objectives and Hypotheses:
- To test the feasibility of using polysomnography to identify the severity of sleep disorders in assisted living residents. The implementation of objective measures of sleep in assisted living residents is practical and provides accurate information on sleep architecture parameters.
- To investigate the association between functional capacity and physical activity and sleep quality in assisted living residents using functional tests and actigraphy, respectively. There is a positive association between functional capacity and sleep quality and physical activity will improve sleep quality in the efficiency and duration domains.
- To investigate the association between sleep quality, measured through actigraphy, and cognitive performance, specifically in the memory domain, in assisted living residents. There is a positive association between sleep quality, especially sleep efficiency, and cognitive performance.
- To compare the sleep quality (measured with polysomnography, actigraphy, and questionnaire) in assisted living residents with older individuals of the same age and cognitive performance (Montreal Cognitive Assessment; MoCA score > 26) who live independently.
Sleep quality will be lower in assisted living residents in comparison with older individuals who live independently and the use of various methods to assess sleep quality will provide a better estimation of the differences in sleep quality between these populations.
- Conditions
- Sleep Disturbance, Aging
- Being tested
- Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance.
- Keywords
- Sleep, Functional Capacity, Cognitive Performance, Assisted-Living Facilities
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance.Behavioural
The first visit will consist of screening measurements. Participants will be asked to complete the following questionnaires: InterRAI Self Report Quality of Life Survey for Long Term Care Facilities (interRAI SQoL), Resident Assessment Instrument (RAI)-MDS 2.0, Global Physical Activity Questionnaire (GPAQ), Memory Complaint Questionnaire (MAC-Q), and Pittsburgh Sleep Quality Index (PSQI). At the end of this visit, the participants will be asked to wear the ActiWatch-2 (AW-2) as a wristwatch for 14 days. In the second visit, participants' height and weight will be measured and the participants will perform the following cognitive and functional tests: MoCA, Brief Visuospatial Memory Test-Revised (BVMT-R), Hopkins Verbal Learning Test-Revised (HVLT-R), Time up and Go (TUG), and Cognitive TUG (TUGcog). Finally, visit 3 will consist of on-site PSG recordings.
| Study group | Role | What they receive |
|---|---|---|
| Assisted-living residents | The target population will be inactive men and women residents of the Brenda Strafford Foundation (> 50 yrs. old). We expect the participants to be classified as inactivity, which will be defined as an engagement in < 3 sessions/week of 20 min or more of vigorous exercise. Participants should be able to move independently without the assistance of a wheelchair. Receives: Behavioral: Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance. | |
| Control group | Volunteers from the Brain in Motion II (BIM II) study (NCT03035851). The BIM II study aims to examine the mechanisms whereby exercise may improve sleep and cognition in men and women aged 50 to 80 years old. As the baseline measurements of the BIM II study are similar to the assessments proposed in this study, the assisted living residents will be matched with older individuals of the same age and cognitive performance who live independently to answer the last research question. Receives: Behavioral: Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time.
The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
Measured: Through study completion, an average of 1 year.
Sleep efficiency.
The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
Measured: Through study completion, an average of 1 year.
Sleep onset latency.
The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
Measured: Through study completion, an average of 1 year.
Number of awakening.
The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
Measured: Through study completion, an average of 1 year.
PSQI component score.
The Pittsburgh Sleep Quality Index (PSQI) will be used to subjectively measure sleep quality and disturbances in the past few months. The self-related questions include the assessment of seven different sleep domains: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The participant should score each of the seven areas from 0 (no difficulty) to 3 (severe difficulty). Final score ≥ 5 indicates poor sleep quality.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (6)
Short-term memory, visuospatial ability, and executive function.
Montreal Cognitive Assessment (MoCA) will be used.
Measured: Through study completion, an average of 1 year.
Visuo-spatial memory.
Visuospatial Memory Test-Revised (BVMT-R) will be used.
Measured: Through study completion, an average of 1 year.
Verbal learning and memory.
Hopkins Verbal Learning Test-Revised (HVLT-R) will be used.
Measured: Through study completion, an average of 1 year.
Functional capacity.
Time up and Go (TUG) task will be performed. The TUG test considers the time the participant takes to stand up from a chair, walk 3 m away, return to the chair, and sit down in the chair again.
Measured: Through study completion, an average of 1 year.
Dual-task capacity.
Cognitive TUG (TUGcog) will be performed. In the TUGcog test, the participant should perform the same task while counting backward from a randomly assigned number between 60 and 100
Measured: Through study completion, an average of 1 year.
Total number of counts (physical activity).
The Actiwatch 2 will be used for 14 days to record total movement and patterns of activity per day.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- The Brenda Strafford Foundation
- Responsible party
- Principal investigator, Marc Poulin, University of Calgary
- Investigators
- Marc J Poulin, PhD, DPhil, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400617
- Sponsor's protocol ID
- REB 19-1939
- Status last verified
- Apr 2026
- First submitted
- 14 May 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Association Between Sleep Quality, Physical Activity, and Memory in Assisted-Living Residents
- ClinicalTrials.gov ID
- NCT04400617
- Acronym / sponsor ID
- REB 19-1939
- Conditions
- Sleep Disturbance, Aging
- Keywords
- Sleep, Functional Capacity, Cognitive Performance, Assisted-Living Facilities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- The Brenda Strafford Foundation
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2020 (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.
Assisted living residents who have sleep disturbances are at great risk of developing cognitive impairments. The identification of factors that increase sleep problems in this population is the first step towards improving sleep disorders and reducing and/or delaying the occurrence of cognitive impairments in this population. Physical activity has been proposed to improve sleep quality in older individuals, but there is currently no scientific evidence of how sleep mediates the relationship between physical activity and cognition in assisted living residents. This is a cross-sectional study that investigates the relationship between sleep quality, functional/physical capacity, and cognitive performance. Participants will be recruited through a non-probabilistic sampling method (convenience) as this is a feasibility study that aims to identify, for the first time, sleep disorders in assisted living residents using objective measures of sleep. Sleep quality will be measured with polysomnography, actigraphy, and questionnaire. Functional and physical capacity will be assessed through walking tasks and actigraphy. Cognitive tasks will be used to assess memory. This study will bring new insights into the factors that affect the quality of life and sleep in assisted living residents. The evidence-based knowledge acquired on-site will be translated and shared with the local and global scientific community to raise awareness of the factors that contribute to increasing institutionalization and dependent living. Results obtained from objective and subjective measures of sleep will be of great importance to develop specialized clinical expertise and behavioral interventions that will meet residents' needs.
Detailed description
Specific Objectives and Hypotheses:
- To test the feasibility of using polysomnography to identify the severity of sleep disorders in assisted living residents. The implementation of objective measures of sleep in assisted living residents is practical and provides accurate information on sleep architecture parameters.
- To investigate the association between functional capacity and physical activity and sleep quality in assisted living residents using functional tests and actigraphy, respectively. There is a positive association between functional capacity and sleep quality and physical activity will improve sleep quality in the efficiency and duration domains.
- To investigate the association between sleep quality, measured through actigraphy, and cognitive performance, specifically in the memory domain, in assisted living residents. There is a positive association between sleep quality, especially sleep efficiency, and cognitive performance.
- To compare the sleep quality (measured with polysomnography, actigraphy, and questionnaire) in assisted living residents with older individuals of the same age and cognitive performance (Montreal Cognitive Assessment; MoCA score > 26) who live independently.
Sleep quality will be lower in assisted living residents in comparison with older individuals who live independently and the use of various methods to assess sleep quality will provide a better estimation of the differences in sleep quality between these populations.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assisted-living residents | – | Behavioral: Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance.The target population will be inactive men and women residents of the Brenda Strafford Foundation (> 50 yrs. old). We expect the participants to be classified as inactivity, which will be defined as an engagement in < 3 sessions/week of 20 min or more of vigorous exercise. Participants should be able to move independently without the assistance of a wheelchair. |
| Control group | – | Behavioral: Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance.Volunteers from the Brain in Motion II (BIM II) study (NCT03035851). The BIM II study aims to examine the mechanisms whereby exercise may improve sleep and cognition in men and women aged 50 to 80 years old. As the baseline measurements of the BIM II study are similar to the assessments proposed in this study, the assisted living residents will be matched with older individuals of the same age and cognitive performance who live independently to answer the last research question. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The target population will be inactive men and women residents of the Brenda Strafford Foundation (> 50 yrs. old).
Key inclusion criteria (2 listed)
- Be inactivity, which will be defined as an engagement in < 3 sessions/week of 20 min or more of vigorous exercise;
- Be able to move independently without the assistance of a wheelchair.
Key exclusion criteria (7 listed)
- Diagnosis of a developmental handicap;
- Residents who are not able to understand communication and be understood by others and do not have decision-making capacity according to the Cognitive Performance Scale (CPS) > 3; The investigators will assess all the resident's capacity with the Brenda Strafford Foundation caregivers, even if their CPS is within the range included in the study (CPS 0-3);
- Terminal illness (life expectancy < 1 year);
- Not fluent in English;
- Currently participating in another trial;
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 |
|---|---|---|
| Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance.The first visit will consist of screening measurements. Participants will be asked to complete the following questionnaires: InterRAI Self Report Quality of Life Survey for Long Term Care Facilities (interRAI SQoL), Resident Assessment Instrument (RAI)-MDS 2.0, Global Physical Activity Questionnaire (GPAQ), Memory Complaint Questionnaire (MAC-Q), and Pittsburgh Sleep Quality Index (PSQI). At the end of this visit, the participants will be asked to wear the ActiWatch-2 (AW-2) as a wristwatch for 14 days. In the second visit, participants' height and weight will be measured and the participants will perform the following cognitive and functional tests: MoCA, Brief Visuospatial Memory Test-Revised (BVMT-R), Hopkins Verbal Learning Test-Revised (HVLT-R), Time up and Go (TUG), and Cognitive TUG (TUGcog). Finally, visit 3 will consist of on-site PSG recordings. | Behavioural | Assisted-living residents, Control group |
Primary outcome
Total sleep time.
Time frame: Through study completion, an average of 1 year.
The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
Sleep efficiency.
Time frame: Through study completion, an average of 1 year.
The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
Sleep onset latency.
Time frame: Through study completion, an average of 1 year.
The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
Number of awakening.
Time frame: Through study completion, an average of 1 year.
The Prodigy Sleep Monitor (polysomnography) and Actiwatch 2 (actigraphy) will be used to analyze this sleep outcome.
PSQI component score.
Time frame: Through study completion, an average of 1 year.
The Pittsburgh Sleep Quality Index (PSQI) will be used to subjectively measure sleep quality and disturbances in the past few months. The self-related questions include the assessment of seven different sleep domains: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The participant should score each of the seven areas from 0 (no difficulty) to 3 (severe difficulty). Final score ≥ 5 indicates poor sleep quality.
6 secondary outcomes
Short-term memory, visuospatial ability, and executive function.
Time frame: Through study completion, an average of 1 year.
Visuo-spatial memory.
Time frame: Through study completion, an average of 1 year.
Verbal learning and memory.
Time frame: Through study completion, an average of 1 year.
Functional capacity.
Time frame: Through study completion, an average of 1 year.
Dual-task capacity.
Time frame: Through study completion, an average of 1 year.
Total number of counts (physical activity).
Time frame: Through study completion, an average of 1 year.
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 1 May 2026.
- Individual participant dataSharing planned: No
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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.
Marc J Poulin, PhD, DPhil principal investigator
University of Calgary
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 Disturbance and Aging, run by University of Calgary 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 2 inclusion and 7 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 1 May 2026. 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 Marc J Poulin, PhD (403.220.8372, poulin@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time. (time frame: Through study completion, an average of 1 year.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026.