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OpenTrials
Completed

NCT Number: NCT04151251

Inpatient Sleep Loss: Educating and Empowering Patients

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.

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Key information

Conditions

Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Patient Empowerment

Behavioral

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

Sleep Kit

Other

Patients receive a small pouch that includes an eye mask, ear plugs, and headphones, all to be used to aid in falling/staying asleep

Primary outcomes

  1. Karolinska Sleep Log - Sleep Times

    Time frame: Through stay in the hospital until discharge, usually 2-3 days

    A self-reported measure of time spent sleeping, time it took to fall asleep, etc.

Secondary outcomes

  1. Frequency of Sleep Disruptions in the Hospital Setting

    Time frame: Through stay in the hospital until discharge, usually 2-3 days

    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.

  2. Patients Who Report Talking to Clinicians About Their Healthcare

    Time frame: Through stay in the hospital until discharge, usually 2-3 days

    Measure of number of patients who advocate for their sleep by making lifestyle changes, including speaking to their clinicians to reduce nighttime disruptions

  3. Number of nighttime disruptions to sleep

    Time frame: Through stay in the hospital until discharge, usually 2-3 days

    Measure of disruptions patients receive between 11 PM and 7 AM, determined by hospital hand sanitizer stations outside doors and electronic health record audits

  4. Karolinska Sleep Log - Outcomes of Sleep

    Time frame: Through stay in the hospital until discharge, usually 2-3 days

    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?"

  5. Actigraphy - Objective Measure of Sleep Duration

    Time frame: During stay at the hospital, for a week after, and for a week three months after discharge

    Actiwatch Spectrum Pros used to determine sleep duration

  6. Actigraphy - Objective Measure of Sleep Quality

    Time frame: During stay at the hospital, for a week after, and for a week three months after discharge

    Actiwatch Spectrum Pros used to determine sleep quality

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Acronym: ISLEEP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 5, 2019
Registry last updated
May 16, 2023

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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