Sleep Enhancing Tools: Pilot Study

Not Applicable

Completed

• Conditions: Sleep; Pain
• Interventions: Behavioral: Sleep Education Presentation; Behavioral: Sleep Tool Demonstration

• Registration Number: NCT02068703
• Lead Sponsor: University of Michigan

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Admitted to a private room in the hospital
• Speak and read english
• expected length of stay > 2 days

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Exclusion Criteria

• Hearing aids
• sleep apnea using positive airway pressure therapy
• medically or behaviorally unstable

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Sleep Education Presentation	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.
Intervention	Sleep Tool Demonstration	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.
Inert Control	Sleep Education Presentation	Same 10 min time exposure and tool delivery to subjects in this arm WITHOUT demonstration.

Primary Outcome Measures

Name	Time	Method
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	Baseline to day 3	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.

Secondary Outcome Measures

Name	Time	Method
Effect of use of sleep tool devices on length of stay	number hospital days between administration of tool and hospital discharge	Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced length of hospital stay

Trial Locations

Locations (1)

UMichigan; 🇺🇸 Ann Arbor, Michigan, United States