Sleepless at Scripps: An Inpatient White Noise Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorScripps Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 18 years old
Admitted to inpatient internal medicine service for at least 3 nights
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Active white noise
DeviceActive white noise of 57 dB - 60 dB from 10 pm to 6 am
Inactive white noise
DeviceSham comparator - white noise machine played at lower decibel level not expected to impact sound level changes
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Night A active white noiseExperimental treatment 1 intervention
Group B: Night B inactive white noiseSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sound level changes ≥ 17.5 dB
Change in sound level changes ≥ 17.5dB between inactive and active white noise intervention. This will be using sound level measurements obtained from sound meters placed in patient rooms
Time frame
72 hours2
Sleep duration
Measured between patients receiving active vs. inactive white noise in minutes using wrist-worn actigraphy devices
Time frame
72 hours3
Sleep fragmentation
Measured using mean and median sleep bout duration from actigraphy devices in patients receiving active vs. inactive white noise.
Time frame
72 hours4
Subjective sleep quality
Measured using Richards Campbell Sleep Questionnaire. Assesses subjective sleep in patients who received active white noise. vs. inactive white noise.
Time frame
72 hoursSecondary outcomes
1
Delirium Incidence
Measured using bCAM. Comparing rates of delirium incidence between patients receiving active vs. inactive white noise.
Time frame
72 hours2
Morning blood glucose
Measured using morning metabolic panels OR point-of-care glucose testing.
Time frame
72 hours3
Morning blood pressure reading
Measured using standard of care vital signs, both systolic and diastolic measurements.
Time frame
72 hours4
Delirium incidence based on sleep fragmentation
Measured using bCAM. In a secondary analysis, the investigators will test whether those individuals with higher sleep fragmentation, as measured by actigraphy, will have a higher incidence of delirium compared to those with lower levels of sleep fragmentation.
Time frame
72 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov