Inpatient Sleep Loss: Educating and Empowering Patients

Sleep Clinical Trial

— ISLEEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151251
• Other study ID #: IRB19-0169
• Status: Completed
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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