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Inpatient Sleep Loss: Educating and Empowering Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04151251
Acronym
ISLEEP
Enrollment
256
Registered
2019-11-05
Start date
2020-01-08
Completion date
2023-03-31
Last updated
2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

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.

Interventions

BEHAVIORALPatient 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

OTHERSleep 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

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

Trained research assistants will introduce the interventions to patients, leaving the outcomes assessor and investigator only able to see results. The care provider is not part of the study decision, as the study does not affect their healthcare.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Karolinska Sleep Log - Sleep TimesThrough stay in the hospital until discharge, usually 2-3 daysA self-reported measure of time spent sleeping, time it took to fall asleep, etc.

Secondary

MeasureTime frameDescription
Patients Who Report Talking to Clinicians About Their HealthcareThrough stay in the hospital until discharge, usually 2-3 daysMeasure of number of patients who advocate for their sleep by making lifestyle changes, including speaking to their clinicians to reduce nighttime disruptions
Number of nighttime disruptions to sleepThrough stay in the hospital until discharge, usually 2-3 daysMeasure of disruptions patients receive between 11 PM and 7 AM, determined by hospital hand sanitizer stations outside doors and electronic health record audits
Frequency of Sleep Disruptions in the Hospital SettingThrough stay in the hospital until discharge, usually 2-3 daysAdministered 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.
Actigraphy - Objective Measure of Sleep DurationDuring stay at the hospital, for a week after, and for a week three months after dischargeActiwatch Spectrum Pros used to determine sleep duration
Actigraphy - Objective Measure of Sleep QualityDuring stay at the hospital, for a week after, and for a week three months after dischargeActiwatch Spectrum Pros used to determine sleep quality
Karolinska Sleep Log - Outcomes of SleepThrough stay in the hospital until discharge, usually 2-3 daysSubjective 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?

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026