NCT04400617 Sleep Quality in Assisted-Living Residents
| NCT ID | NCT04400617 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Sleep Disturbance |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Marc J Poulin, PhD, DPhil
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT04400617 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Sleep Disturbance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04400617 currently recruiting?
Yes, NCT04400617 is actively recruiting participants. Contact the research team at poulin@ucalgary.ca for enrollment information.
Where is the NCT04400617 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT04400617 clinical trial?
NCT04400617 is sponsored by University of Calgary. The principal investigator is Marc J Poulin, PhD, DPhil at University of Calgary. The trial plans to enroll 150 participants.