Self-Management of Sleep Among Older Adults

Study Overview
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Brief Summary
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The purpose of this study is to test the feasibility of older persons use of a personal sleep monitoring device(PSMD)to improve self-management of sleep. Disrupted sleep occurs in up to 50% of persons over the age of 65 with chronic health conditions. Impaired sleep negatively influences subjective and objective health outcomes.To improve their sleep, older adults with chronic health conditions could benefit from objective information, available through personal health monitoring devices, about their current and changing sleep patterns. Based on this information, sleep self-management interventions can be individualized and shared, and associations between sleep and health changes may be better managed.

Official Title
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Self-Management of Sleep Among Older Adults Using Personal Monitoring: A Feasibility Study

Conditions
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Sleep Disturbance

Intervention / Treatment
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* Device: Personal Sleep Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 years or older Self-report difficulty sleeping Willingness to wear the PSMD for four weeks Cognitive abilities (Mini Cog of 5 or above). Exclusion Criteria: Under the age of 65 Presence of known sleep disorders Severe cognitive or neurosensory impairment

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparative control - 3 group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Passive Personal Sleep Monitoring<br>Wears personal sleep monitor but does not actively self-monitor (will have access to the sleep data and self-monitoring after 4 weeks). | Device: Personal Sleep Monitoring<br>* Wearable Sleep Self-Monitoring Device (Actigraphy)<br>* Other names: Personal Sleep Monitor;|
| Active Comparator: Individual Personal Sleep Monitoring<br>Wears personal sleep monitor and actively self-monitoring sleep and using data to self-manage sleep. | Device: Personal Sleep Monitoring<br>* Wearable Sleep Self-Monitoring Device (Actigraphy)<br>* Other names: Personal Sleep Monitor;|
| Active Comparator: Socially Supported Sleep Monitoring<br>Wears a personal sleep monitor, actively self-monitoring using sleep data to self-manage sleep and shares data for supportive self-management. | Device: Personal Sleep Monitoring<br>* Wearable Sleep Self-Monitoring Device (Actigraphy)<br>* Other names: Personal Sleep Monitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of A Personal Sleep Monitoring Device (PSMD) | Demonstrates use of Personal Sleep Self-Monitor through data downloads and self-report | up to 4 weeks | 
| Changes in Sleep | Demonstrated sleep changes indicated by change in BRCS NINR PROMIS SF V1 Sleep Disturbance Scale 6a (a 6 item, 5 point likert scale with higher scores reflecting more sleep disturbance and lower scores less. | Week 1 and Week 4 | 
| Changes in Health | Demonstrated health changes indicated by change in BRCS NINR PROMIS Global Health Short Form Scale 10a (10 item, 5 point likert scale) with higher scores reflecting better health (3 items reverse scoring) | Week 1 and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of PSMD | Demonstrated through adapted System Usability Scale Scores (10 items, 5 point likert scale) with high agreement demonstrating higher levels of satisfaction using the device | Week 2 and 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Disturbance, Older People, Self-Monitoring, Self-Management, Social Support, Wrist-worn Actigraphy