Self-Management of Sleep Among Older Adults

Early Phase 1

Completed

• Conditions: Sleep Disturbance
• Interventions: Device: Personal Sleep Monitoring

• Registration Number: NCT03837249
• Lead Sponsor: University of Massachusetts, Amherst

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-24
• Study Start: 2019-02-04
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-12
• Primary Completion: 2019-08-30
• Study Completion: 2020-01-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual Personal Sleep Monitoring	Personal Sleep Monitoring	Wears personal sleep monitor and actively self-monitoring sleep and using data to self-manage sleep.
Socially Supported Sleep Monitoring	Personal Sleep Monitoring	Wears a personal sleep monitor, actively self-monitoring using sleep data to self-manage sleep and shares data for supportive self-management.
Passive Personal Sleep Monitoring	Personal Sleep Monitoring	Wears personal sleep monitor but does not actively self-monitor (will have access to the sleep data and self-monitoring after 4 weeks).

Primary Outcome Measures

Name	Time	Method
Use of A Personal Sleep Monitoring Device (PSMD)	up to 4 weeks	Demonstrates use of Personal Sleep Self-Monitor through data downloads and self-report
Changes in Sleep	Week 1 and Week 4	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.
Changes in Health	Week 1 and Week 4	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Massachusetts; 🇺🇸 Amherst, Massachusetts, United States