Sleep Enhancing Tools: Pilot Study

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068703
• Other study ID #: HUM00075628
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: June 27, 2016
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pain
• Sleep

Intervention

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

Locations

Country	Name	City	State
United States	UMichigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	baseline to day 3	No
Other	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	baseline to day 3	No
Primary	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	No
Secondary	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	number hospital days between administration of tool and hospital discharge	No