Self-Management of Sleep Among Older Adults

NCT03837249 | Completed Early Phase 1

• 1 other identifier: 2018-5225
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance

Keywords

Older People; Sleep Disturbance; Self-Monitoring; Self-Management; Social Support; Wrist-worn Actigraphy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Usability of PSMD

  Week 2 and 4

Study Arms (3)

Passive Personal Sleep Monitoring

PLACEBO COMPARATOR

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

Individual Personal Sleep Monitoring

ACTIVE COMPARATOR

Wears personal sleep monitor and actively self-monitoring sleep and using data to self-manage sleep.

Device: Personal Sleep Monitoring

Socially Supported Sleep Monitoring

ACTIVE COMPARATOR

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

Interventions

Personal Sleep Monitoring DEVICE

Wearable Sleep Self-Monitoring Device (Actigraphy)

Also known as: Personal Sleep Monitor

Individual Personal Sleep Monitoring; Passive Personal Sleep Monitoring; Socially Supported Sleep Monitoring

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years or older
• Self-report difficulty sleeping
• Willingness to wear the PSMD for four weeks
• Cognitive abilities (Mini Cog of 5 or above).

You may not qualify if:

• Under the age of 65
• Presence of known sleep disorders
• Severe cognitive or neurosensory impairment

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead

Study Sites (1)

University of Massachusetts

Amherst, Massachusetts, 01003, United States

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Raeann G LeBlanc, PhD, DNP

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: One group - personal sleep monitoring data with-held then provided after the intervention period.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: Comparative control - 3 group

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 12, 2019
• Study Start: February 4, 2019
• Primary Completion: August 30, 2019
• Study Completion: January 30, 2020
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)