An interventional study of Patient Empowerment and Sleep Kit in Sleep, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by University of Chicago · Not applicable, Interventional, and Other
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.
University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
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Exclusion Criteria:
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
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.
Behavioral: Patient Empowerment · Other: Sleep Kit
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
Patients receive a small pouch that includes an eye mask, ear plugs, and headphones, all to be used to aid in falling/staying asleep
Karolinska Sleep Log - Sleep Times
A self-reported measure of time spent sleeping, time it took to fall asleep, etc.
Time frame: Through stay in the hospital until discharge, usually 2-3 days
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.
Time frame: 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
Time frame: 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
Time frame: 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?"
Time frame: 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
Time frame: 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
Time frame: During stay at the hospital, for a week after, and for a week three months after discharge
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Deidentified data will be available to researchers by request
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Chicago