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Completed

NCT Number: NCT02068703

Sleep Enhancing Tools: Pilot Study

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.

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Key information

Conditions

Sleep Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMichigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sleep Education Presentation

Behavioral

Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.

Sleep Tool Demonstration

Behavioral

Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools to improve sleep.

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

    Time frame: 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 outcomes

  1. Effect of use of sleep tool devices on length of stay

    Time frame: 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

Other outcomes

  1. Effect of sleep enhancing tools on medication use

    Time frame: baseline to day 3

    Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced use of sleep or pain medication

  2. Effect of sleep enhancing tools on participation in Occupational therapy

    Time frame: baseline to day 3

    Whether the intervention of using sleep enhancing tools will translate into increased number of days participating in therapy during the study

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Use of Sleep Enhancing Tools Impact on Self-Reported Sleep Survey

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 21, 2014
Registry last updated
Jun 28, 2016

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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