Recruiting

White Noise

Sponsor:

Scripps Health

Code:

NCT05475262

Conditions

White Noise

Sleep

Sleep Fragmentation

Sleep Duration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active white noise

Inactive white noise

Study Details

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.

Conditions

White Noise

Sleep

Sleep Fragmentation

Sleep Duration

Study ID

NCT05475262

Start date

Jul 28, 2022

Status verified date

Jan, 2024

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Over 18 years old
  • Admitted to inpatient internal medicine service for at least 3 nights

Exclusion Criteria:

-

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Active white noise

Active white noise of 57 dB - 60 dB from 10 pm to 6 am

Inactive white noise

Sham comparator - white noise machine played at lower decibel level not expected to impact sound level changes

Primary outcome measure

  • Sound level changes ≥ 17.5 dB [ Time Frame: 72 hours ]
  • Sleep duration [ Time Frame: 72 hours ]
  • Sleep fragmentation [ Time Frame: 72 hours ]
  • Subjective sleep quality [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Locations

Scripps Health

Recruiting

La Jolla, California, United States, 92037

Contacts

More Information

Sponsor

Scripps Health

Last update posted

Jan 24, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Health on 2024-01-24.