Self-Management of Sleep Among Older Adults

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837249
• Other study ID #: 2018-5225
• Status: Completed
• Phase: Early Phase 1
• Start date: February 4, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: February 2020
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 30, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Device:
• Personal Sleep Monitoring
Wearable Sleep Self-Monitoring Device (Actigraphy)

Locations

Country	Name	City	State
United States	University of Massachusetts	Amherst	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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