Sleepless at Scripps: An Inpatient White Noise Study

NCT05475262 | Recruiting FDA Device

• 1 other identifier: White noise
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

  72 hours

• Sleep duration

  Measured between patients receiving active vs. inactive white noise in minutes using wrist-worn actigraphy devices

  72 hours

• Sleep fragmentation

  Measured using mean and median sleep bout duration from actigraphy devices in patients receiving active vs. inactive white noise.

  72 hours

• Subjective sleep quality

  Measured using Richards Campbell Sleep Questionnaire. Assesses subjective sleep in patients who received active white noise. vs. inactive white noise.

  72 hours

Secondary Outcomes (7)

• Delirium Incidence

  72 hours

• Morning blood glucose

  72 hours

• Morning blood pressure reading

  72 hours

• Delirium incidence based on sleep fragmentation

  72 hours

• Morning blood pressure based on sleep fragmentation

  72 hours

Study Arms (2)

Night A active white noise

EXPERIMENTAL

Patients receiving active level of white noise on night A

Device: Active white noise

Night B inactive white noise

SHAM COMPARATOR

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.

Device: Inactive white noise

Interventions

Active white noise DEVICE

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

Night A active white noise

Inactive white noise DEVICE

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

Also known as: Sham comparator

Night B inactive white noise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Scripps Health: lead

Study Sites (1)

Scripps Health

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Stuti Jaiswal, MD, PhD

CONTACT

858-554-7909; JAISWAL.STUTI@SCRIPPSHEALTH.ORG

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 26, 2022
• Study Start: July 28, 2022
• Primary Completion: January 1, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

US (1)