Clinical Trial

Sleepless at Scripps: An Inpatient White Noise Study

Recruiting
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Record status
This record was last updated January 24, 2024 (before its estimated January 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
Sleep is an important part of the healing process, and patients admitted to the hospital often report poor sleep. Patients have difficulty not only falling sleep, but also staying asleep. Prior studies show that hospital noise may be a contributing factor, and in particular, sound level changes (which refers to an increase in sound above the background/baseline noise level) may cause arousals from sleep. Based on preliminary data, this study aims to use white noise to reduce the number of relevant sound level changes that occur during a night of sleep in the hospital. Using a randomized, cross-over design, the investigators aim to enroll 45 inpatient adults (age ≥ 65 years) to receive "active," white noise (white noised played at 57-60 decibels) on one night of their stay, and "inactive," white noise (white noise played at 45-50 decibels) on an alternate night. Three major primary outcomes will be investigated - 1) objective sleep duration as measured using actigraphy, 2)objectively measured sleep fragmentation using actigraphy, and 3) subjective sleep quality using the Richards Campbell Sleep Questionnaire. Secondary outcomes will include sound level changes in the room (measured using sound meters), as well as morning blood glucose (for diabetic/prediabetic patients) and blood pressure measurements. Delirium will be measured twice daily through the inpatient stay in a secondary analysis to compare levels of sleep fragmentation to delirium incidence.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-07-24.
Status change: Not Yet Recruiting → Recruiting 2024-01-22
Trial Details
NCT Number NCT05475262
Lead Sponsor Scripps Health
Conditions White Noise, Sleep, Sleep Fragmentation, Sleep Duration
Enrollment 50 participants
Start Date 2022-07-28
Primary Completion 2025-01-01 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2024-01-24