An interventional study of Sleep Education Presentation and Sleep Tool Demonstration in Sleep and Pain, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-06-28.
Sponsored by University of Michigan · Not applicable, Interventional, and Health services research
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.
A randomized, clinical pilot to trial the effect of sleep tools on patients' perception of sleep within the hospital setting.
We propose to conduct this pilot study to improve subjective symptoms of sleep deprivation in non-ICU hospitalized subjects by performing a brief intervention, easily performed at the point of care. Given the heterogeneity of hospitalized patients with varying ages, co-morbidities and other factors (such as pain and fatigue), we felt that an initial pilot study should focus on acceptability of three sleep aids (ear plugs, eye masks and white noise machine) among hospitalized non-ICU patients. Patients will be able to choose which aid they use and will be allowed to change aids during their hospital stay.
The primary outcomes of this study will be 1) improvement in perceived sleep quality as measured by PROMIS, a validated patient-reported outcome information system and 2) quality of care measures (length of stay, medication use and participation in therapy sessions).
PROMIS (Patient Reported Outcomes Measurement Information System) is an NIH sponsored health survey tool.
Information on characteristics (both patient and environment) including demographics, illness severity, number of medications, specific medications (such as sedatives and pain medications) will be collected to examine which predictors of improved perception of sleep quality correlate with use of sleep aids. This study is intended to focus on modifying the environment at the patient level rather than addressing the sources of environmental hospital noise.
Our study has the potential to impact this field with a preventative education based intervention, using simple tools in the non-ICU setting. It is important to understand this is not a study measuring sleep objectively but whether hospitalized patients perceive they sleep better if sleep aids are used.
University of Michigan is the lead sponsor of 1,476 studies on the registry; 197 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects 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.
Behavioral: Sleep Education Presentation · Behavioral: Sleep Tool Demonstration
Same 10 min time exposure and tool delivery to subjects in this arm WITHOUT demonstration.
Behavioral: Sleep Education Presentation
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.
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.
Time frame: Baseline to day 3
Effect of use of sleep tool devices on length of stay
Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced length of hospital stay
Time frame: number hospital days between administration of tool and hospital discharge
Effect of sleep enhancing tools on medication use
Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced use of sleep or pain medication
Time frame: baseline to day 3
Effect of sleep enhancing tools on participation in Occupational therapy
Whether the intervention of using sleep enhancing tools will translate into increased number of days participating in therapy during the study
Time frame: baseline to day 3
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of Michigan