Inpatient Sleep Loss: Educating and Empowering Patients (ISLEEP)

Mentoring Patient-Oriented Research: Sleep & Health During & After Hospital Stay

While many interventions have targeted hospital staff to improve sleep, few have been successful, and often suffer from limited adherence to staff protocols. Given preliminary data that suggests that empowered patients are more likely to obtain better sleep and have objectively lower noise levels in their rooms, it is plausible that partnering directly with patients can mitigate sleep loss and improve health outcomes. Patients will be randomized to receive the I-SLEEP education and empowerment program and test the effectiveness of this program on patient sleep and health outcome in the hospital and post-discharge. The aim of the project is to reduce environmental, healthcare-related, and patient-related factors that disrupt sleep of hospitalized patients by use of patient education and empowerment intervention.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Other: Sleep Kit; Behavioral: Patient Empowerment

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University Of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Admitted to the general/hospitalist medicine departments
• Stayed at least one night in hospital since admission

Exclusion Criteria:

• Admitted >72 hours ago
• Patient has been diagnosed with a sleep disorder such as narcolepsy, insomnia, or sleep apnea
• Patient was transferred from ICU or outside hospital
• Patient under strict, droplet, or airborne isolation precautions
• Unable to ambulate
• Too confused or incoherent to provide consent
• Patient cannot speak English
• Pregnancy
• Residence in a nursing home or assisted living facility
• Patient was admitted in a hospital within two weeks of current admission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sleep Kit Alone; Patients who are not randomized into the I-SLEEP intervention will receive a sleep kit that includes an eye mask, earplugs, and headphones.They will still receive the usual standard of care provided by clinicians which includes measures to reduce unnecessary nighttime disruptions and limiting excessive noise within the hospital setting.	Other: Sleep Kit; Patients receive a small pouch that includes an eye mask, ear plugs, and headphones, all to be used to aid in falling/staying asleep
Experimental: Sleep Kit + Empowerment; A short video will be shown on iPads and a brochure will be given that both describe the importance of good sleep and how to facilitate it with good sleep hygiene. The video will show a few reasons why someone might not get optimal sleep while in a hospital, and offer advice to address this from a doctor. The brochure will be kept to no higher than a 6th grade reading level, considered optimal for health education materials. Text will be kept brief and to the point. To account for vision problems, we will use >12-point font & leave a large portion of each page empty. Visual Aids & graphics will be employed when possible. All of this is given in addition to the usual standard of care provided by clinicians.	Other: Sleep Kit; Patients receive a small pouch that includes an eye mask, ear plugs, and headphones, all to be used to aid in falling/staying asleep; Behavioral: Patient Empowerment; Group to receive a 5 minute video about typical hospital sleep disruptions and what they can do to prevent them, as well as a brochure outlining the importance of sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Karolinska Sleep Log - Sleep Times	A self-reported measure of time spent sleeping, time it took to fall asleep, etc.	Through stay in the hospital until discharge, usually 2-3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Sleep Disruptions in the Hospital Setting	Administered to obtain a subjective view of typical disruptions to sleep such as bed comfort, room temperature, and pain. Items will also assess the disruptions that are caused by healthcare, such as vital signs, medication administration, and lab-work. This survey includes an item on how disruptive noise was to the patient's sleep, broken down into as many sources of hospital noise as possible.	Through stay in the hospital until discharge, usually 2-3 days
Patients Who Report Talking to Clinicians About Their Healthcare	Measure of number of patients who advocate for their sleep by making lifestyle changes, including speaking to their clinicians to reduce nighttime disruptions	Through stay in the hospital until discharge, usually 2-3 days
Number of nighttime disruptions to sleep	Measure of disruptions patients receive between 11 PM and 7 AM, determined by hospital hand sanitizer stations outside doors and electronic health record audits	Through stay in the hospital until discharge, usually 2-3 days
Karolinska Sleep Log - Outcomes of Sleep	Subjective quality of sleep as determined by scales such as "On a scale of 1 to 5, with 5 being the most, how refreshed did you feel upon waking up this morning?"	Through stay in the hospital until discharge, usually 2-3 days
Actigraphy - Objective Measure of Sleep Duration	Actiwatch Spectrum Pros used to determine sleep duration	During stay at the hospital, for a week after, and for a week three months after discharge
Actigraphy - Objective Measure of Sleep Quality	Actiwatch Spectrum Pros used to determine sleep quality	During stay at the hospital, for a week after, and for a week three months after discharge

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Vineet Arora, MD, MAPP, Medical Researcher

Publications and helpful links

General Publications

• Arora VM, Machado N, Anderson SL, Desai N, Marsack W, Blossomgame S, Tuvilleja A, Ramos J, Francisco MA, LaFond C, Leung EK, Valencia A, Martin SK, Meltzer DO, Farnan JM, Balachandran J, Knutson KL, Mokhlesi B. Effectiveness of SIESTA on Objective and Subjective Metrics of Nighttime Hospital Sleep Disruptors. J Hosp Med. 2019 Jan;14(1):38-41. doi: 10.12788/jhm.3091.
• Adachi M, Staisiunas PG, Knutson KL, Beveridge C, Meltzer DO, Arora VM. Perceived control and sleep in hospitalized older adults: a sound hypothesis? J Hosp Med. 2013 Apr;8(4):184-90. doi: 10.1002/jhm.2027. Epub 2013 Mar 18.
• Mason NR, Orlov NM, Anderson S, Byron M, Mozer C, Arora VM. Piloting I-SLEEP: a patient-centered education and empowerment intervention to improve patients' in-hospital sleep. Pilot Feasibility Stud. 2021 Aug 19;7(1):161. doi: 10.1186/s40814-021-00895-z.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB19-0169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified data will be available to researchers by request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No