Sleep Quality in Assisted-Living Residents

April 27, 2026 updated by: Marc Poulin, University of Calgary

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Specific Objectives and Hypotheses:

  1. 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.

  2. 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.

  3. 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.

  4. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Recruiting
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The target population will be inactive men and women residents of the Brenda Strafford Foundation (> 50 yrs. old).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short-term memory, visuospatial ability, and executive function.
Time Frame: Through study completion, an average of 1 year.
Montreal Cognitive Assessment (MoCA) will be used.
Through study completion, an average of 1 year.
Visuo-spatial memory.
Time Frame: Through study completion, an average of 1 year.
Visuospatial Memory Test-Revised (BVMT-R) will be used.
Through study completion, an average of 1 year.
Verbal learning and memory.
Time Frame: Through study completion, an average of 1 year.
Hopkins Verbal Learning Test-Revised (HVLT-R) will be used.
Through study completion, an average of 1 year.
Functional capacity.
Time Frame: Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.
Dual-task capacity.
Time Frame: Through study completion, an average of 1 year.
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
Through study completion, an average of 1 year.
Total number of counts (physical activity).
Time Frame: Through study completion, an average of 1 year.
The Actiwatch 2 will be used for 14 days to record total movement and patterns of activity per day.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Calgary

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Brenda Strafford Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc J Poulin, PhD, DPhil, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB 19-1939

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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