Clinical trial NCT04400617: Sleep Quality in Assisted-Living Residents
Official title: Understanding the Association Between Sleep Quality, Physical Activity, and Memory in Assisted-Living Residents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disturbance
Aging
Keywords: Sleep
Functional Capacity
Cognitive Performance
Assisted-Living Facilities
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: The Brenda Strafford Foundation
First posted: 2020-05-22
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total sleep time.
timeFrame: Through study completion, an average of 1 year.
measure: Sleep efficiency.
timeFrame: Through study completion, an average of 1 year.
measure: Sleep onset latency.
timeFrame: Through study completion, an average of 1 year.
measure: Number of awakening.
timeFrame: Through study completion, an average of 1 year.
measure: PSQI component score.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Short-term memory, visuospatial ability, and executive function.
timeFrame: Through study completion, an average of 1 year.
measure: Visuo-spatial memory.
timeFrame: Through study completion, an average of 1 year.
measure: Verbal learning and memory.
timeFrame: Through study completion, an average of 1 year.
measure: Functional capacity.
timeFrame: Through study completion, an average of 1 year.
measure: Dual-task capacity.
timeFrame: Through study completion, an average of 1 year.
measure: Total number of counts (physical activity).
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Marc J Poulin, PhD
role: PRINCIPAL_INVESTIGATOR
References: