- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04400617
Sleep Quality in Assisted-Living Residents
Understanding the Association Between Sleep Quality, Physical Activity, and Memory in Assisted-Living Residents
Study Overview
Status
Conditions
Detailed Description
Specific Objectives and Hypotheses:
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.
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.
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.
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marc J Poulin, PhD
- Phone Number: 403.220.8372
- Email: poulin@ucalgary.ca
Study Contact Backup
- Name: Renata L Kruger, PhD
- Phone Number: 403.210.6506
- Email: renata.kruger@ucalgary.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc J Poulin, PhD, University of Calgary
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB 19-1939
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Sleep Disturbance
-
Università degli Studi di BresciaCompletedSleep Phase Rhythm DisturbanceItaly
-
The First Affiliated Hospital of Xiamen UniversityNot yet recruitingPostoperative Sleep Disturbance
-
Riphah International UniversityCompletedSleep Disturbance in AthletesPakistan
-
University of BergenGlamoxCompletedSleep | Sleep Deprivation | Shift-Work Related Sleep DisturbanceNorway
-
Sam Houston State UniversityThe University of Texas Health Science Center, Houston; Memorial Hermann Texas...CompletedSleep Disturbance in Hospitalized Antepartum PatientsUnited States
-
Pacific UniversityCompletedInsomnia | Shift-Work Related Sleep DisturbanceUnited States
-
Erasmus Medical CenterNational Institute for Public Health and the Environment (RIVM); Netherlands...RecruitingShift-Work Related Sleep DisturbanceNetherlands
-
University of California, San FranciscoRecruiting
-
University of North Carolina, Chapel HillWinclove Probiotics B.V.; National Strength and Conditioning Association FoundationCompletedHealthy | Shift-Work Related Sleep DisturbanceUnited States
-
University of ArizonaWalter Reed Army Institute of Research (WRAIR)CompletedSleep Deprivation | Caffeine | Shift-Work Related Sleep DisturbanceUnited States