Clinical trial NCT02068703: Sleep Enhancing Tools: Pilot Study
Official title: Use of Sleep Enhancing Tools Impact on Self-Reported Sleep Survey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Pain
Keywords: survey
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline to day 3
Secondary outcomes:
measure: Effect of use of sleep tool devices on length of stay
timeFrame: number hospital days between administration of tool and hospital discharge
Other outcomes:
measure: Effect of sleep enhancing tools on medication use
timeFrame: baseline to day 3
measure: Effect of sleep enhancing tools on participation in Occupational therapy
timeFrame: baseline to day 3
Locations:
city: Ann Arbor
country: United States
facility: UMichigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Peter Farrehi, MD
role: PRINCIPAL_INVESTIGATOR
References: