Sleep Enhancing Tools: Pilot Study
Use of Sleep Enhancing Tools Impact on Self-Reported Sleep Survey
1 other identifier
interventional
120
1 country
1
Brief Summary
To demonstrate whether use of sleep enhancing aids (face mask, ear plugs or white noise machine) in hospitalized patients can positively affect subjective symptoms of sleep quality, fatigue and pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 19, 2014
CompletedFirst Posted
Study publicly available on registry
February 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJune 28, 2016
June 1, 2016
1.6 years
February 19, 2014
June 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Aggregate change in sleep /pain / fatigue scores on Patient Reported Outcomes Measurement Information System (PROMIS) survey sampled in hospital from baseline to day 3 between study groups
Change from baseline in sleep / pain / fatigue scores on PROMIS survey in the hospital. Each score ranges from 1-5, 1 equals not at all; 5 equals Very much.
Baseline to day 3
Secondary Outcomes (1)
Effect of use of sleep tool devices on length of stay
number hospital days between administration of tool and hospital discharge
Other Outcomes (2)
Effect of sleep enhancing tools on medication use
baseline to day 3
Effect of sleep enhancing tools on participation in Occupational therapy
baseline to day 3
Study Arms (2)
Intervention
ACTIVE COMPARATORSubjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools (face mask, ear plugs and white noise machine) to improve sleep.
Inert Control
PLACEBO COMPARATORSame 10 min time exposure and tool delivery to subjects in this arm WITHOUT demonstration.
Interventions
Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.
Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools to improve sleep.
Eligibility Criteria
You may qualify if:
- Admitted to a private room in the hospital
- Speak and read english
- expected length of stay \> 2 days
You may not qualify if:
- Hearing aids
- sleep apnea using positive airway pressure therapy
- medically or behaviorally unstable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMichigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Farrehi, MD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
February 19, 2014
First Posted
February 21, 2014
Study Start
February 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
June 28, 2016
Record last verified: 2016-06