Sleepless at Scripps: An Inpatient White Noise Study

Part of paid clinical trials in La Jolla, California.

Sponsor
Scripps Health
Study ID
NCT05475262
Status
Recruiting
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Conditions

  • Sleep
  • Sleep Duration
  • Sleep Fragmentation
  • White Noise

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active white noise — DEVICE
    Active white noise of 57 dB - 60 dB from 10 pm to 6 am
  • Inactive white noise — DEVICE
    Sham comparator - white noise machine played at lower decibel level not expected to impact sound level changes

Study Details

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.

Key Dates

Start date
Jul 28, 2022
Status verified
Jan 2024
Primary completion
Jan 1, 2025
Completion
Feb 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Night A active white noise
    Patients receiving active level of white noise on night A
  • Sham Comparator: Night B inactive white noise
    Patients will receive a lower Level of white noise on night B. Termed "inactive," because do not expect the level to have a noticeable change in sound level changes, and thus sleep.

Primary Outcome Measure

Sound level changes ≥ 17.5 dB [ Time Frame: 72 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps HealthLa JollaCalifornia92037
Shelly L Meese
[email protected]
636-893-4407

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Scripps Health· La Jolla, CA

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