NCT04151251: ISLEEP

Inpatient Sleep Loss: Educating and Empowering Patients

Completed NA Last updated 16 May 2023

What this trial tests

NA trial testing Patient Empowerment in Sleep in 256 participants. Completed in 31 March 2023.

Timeline

8 January 2020

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	University of Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	256
Start date	8 January 2020
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Patient Empowerment
• Sleep Kit

Conditions studied

• Sleep — all drugs for Sleep →

Sponsor

University of Chicago

Who can join

18 and older, any sex, with Sleep. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Piloting I-SLEEP: a patient-centered education and empowerment intervention to improve patients' in-hospital sleep.
   Mason NR, Orlov NM, Anderson S, Byron M, et al · · 2021 · cited 2× · PMID 34412696 · DOI 10.1186/s40814-021-00895-z
2. A randomized trial of I-SLEEP: A patient education and empowerment intervention on inpatient sleep duration and medical sleep disruptions.
   Sunderrajan A, Cursio J, Mason N, Byron M, et al · · 2026 · PMID 41645885 · DOI 10.1002/jhm.70273