Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT04400617

Conditions

Sleep Disturbance

Aging

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance.

Study Details

Brief 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 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.

Conditions

Sleep Disturbance

Aging

Study ID

NCT04400617

Start date

Jan 1, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Total sleep time. [ Time Frame: Through study completion, an average of 1 year. ]
  • Sleep efficiency. [ Time Frame: Through study completion, an average of 1 year. ]
  • Sleep onset latency. [ Time Frame: Through study completion, an average of 1 year. ]
  • Number of awakening. [ Time Frame: Through study completion, an average of 1 year. ]
  • PSQI component score. [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts and Locations

Central contacts

Marc J Poulin, PhD

403.220.8372poulin@ucalgary.ca

Shane Magnison-Benoit, BSc

403.220.8372shane.magnisonbenoit@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4N1

More Information

Sponsor

University of Calgary

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Sleep
  • Functional Capacity
  • Cognitive Performance
  • Assisted-Living Facilities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-05-01.