NCT04400617

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jan 2023Dec 2027

First Submitted

Initial submission to the registry

May 14, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
2.6 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

May 14, 2020

Last Update Submit

April 27, 2026

Conditions

Keywords

SleepFunctional CapacityCognitive PerformanceAssisted-Living Facilities

Outcome Measures

Primary Outcomes (5)

  • Total sleep time.

    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.

    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.

    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.

    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.

    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 Outcomes (6)

  • Short-term memory, visuospatial ability, and executive function.

    Through study completion, an average of 1 year.

  • Visuo-spatial memory.

    Through study completion, an average of 1 year.

  • Verbal learning and memory.

    Through study completion, an average of 1 year.

  • Functional capacity.

    Through study completion, an average of 1 year.

  • Dual-task capacity.

    Through study completion, an average of 1 year.

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Assisted-living residentsControl group

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

MeSH Terms

Conditions

Parasomnias

Interventions

Functional Status

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Activities of Daily LivingRehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Marc J Poulin, PhD, DPhil

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc J Poulin, PhD

CONTACT

Shane Magnison-Benoit, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 22, 2020

Study Start

January 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations