NCT05475262 Sleepless at Scripps: An Inpatient White Noise Study
| NCT ID | NCT05475262 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Scripps Health |
| Condition | White Noise |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-07-28 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-07-28 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Over 18 years old * Admitted to inpatient internal medicine service for at least 3 nights Exclusion Criteria: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05475262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying White Noise. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05475262 currently recruiting?
Yes, NCT05475262 is actively recruiting participants. Contact the research team at JAISWAL.STUTI@SCRIPPSHEALTH.ORG for enrollment information.
Where is the NCT05475262 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT05475262 clinical trial?
NCT05475262 is sponsored by Scripps Health. The trial plans to enroll 50 participants.