Clinical trial NCT04151251: Inpatient Sleep Loss: Educating and Empowering Patients
Official title: Mentoring Patient-Oriented Research: Sleep & Health During & After Hospital Stay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Karolinska Sleep Log - Sleep Times
timeFrame: Through stay in the hospital until discharge, usually 2-3 days
Secondary outcomes:
measure: Frequency of Sleep Disruptions in the Hospital Setting
timeFrame: Through stay in the hospital until discharge, usually 2-3 days
measure: Patients Who Report Talking to Clinicians About Their Healthcare
timeFrame: Through stay in the hospital until discharge, usually 2-3 days
measure: Number of nighttime disruptions to sleep
timeFrame: Through stay in the hospital until discharge, usually 2-3 days
measure: Karolinska Sleep Log - Outcomes of Sleep
timeFrame: Through stay in the hospital until discharge, usually 2-3 days
measure: Actigraphy - Objective Measure of Sleep Duration
timeFrame: During stay at the hospital, for a week after, and for a week three months after discharge
measure: Actigraphy - Objective Measure of Sleep Quality
timeFrame: During stay at the hospital, for a week after, and for a week three months after discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: Medical Researcher
name: Vineet Arora, MD, MAPP
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.