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Completed

NCT Number: NCT03837249

Self-Management of Sleep Among Older Adults

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.

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Key information

Conditions

Sleep Disturbance Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Massachusetts

Amherst, Massachusetts, 01003, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personal Sleep Monitoring

Device

Wearable Sleep Self-Monitoring Device (Actigraphy)

Other names: Personal Sleep Monitor

Primary outcomes

  1. Use of A Personal Sleep Monitoring Device (PSMD)

    Time frame: up to 4 weeks

    Demonstrates use of Personal Sleep Self-Monitor through data downloads and self-report

  2. Changes in Sleep

    Time frame: 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.

  3. Changes in Health

    Time frame: 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 outcomes

  1. Usability of PSMD

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 12, 2019
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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