The Effect of White and Pink Noise on Hospitalized Older Adults

The purpose of this study is to determine if using an over-the-counter, commercially available sleep noise machine playing pink or white noise will reduce the incidence of delirium in hospitalized patients over the age of 65. Delirium is an acute change in cognition which commonly occurs in hospitalized older adults, and is linked with sleep-wake cycle disturbance. Delirium is associated with increased morbidity and mortality as well as longer hospital stays. This project will record delirium screening scores for those receiving the intervention and comparing them to baseline data. Reducing delirium rates using a noninvasive, inexpensive method in a hospital setting could have a significant impact on patient outcomes and potentially reduce costs associated with longer hospital stays. It is anticipated that white/pink noise played at night will decrease rates of delirium in hospitalized older adults.

Study Overview

• Status: Completed
• Conditions: Delirium in Old Age
• Intervention / Treatment: Device: White/Pink Noise; Other: Control Group

Detailed Description

The purpose of this study is to determine if using an over-the-counter, commercially available sleep noise machine playing pink or white noise will reduce the incidence of delirium in hospitalized patients over the age of 65. Delirium is an acute change in cognition which commonly occurs in hospitalized older adults, and is linked with sleep-wake cycle disturbance. Delirium is associated with increased morbidity and mortality as well as longer hospital stays. This project will record Nursing Delirium Screening (Nu-DESC) scores for those receiving the intervention and comparing them to baseline data. Reducing delirium rates using a noninvasive, inexpensive method in a hospital setting could have a significant impact on patient outcomes and potentially reduce costs associated with longer hospital stays.

This protocol is based on two concepts. The first is that white/pink noise aids in promoting both sleep quality and quantity and the second is that poor sleep is associated with delirium. Therefore, it stands to reason that improving sleep may decrease the rate of delirium. It is well documented that the elderly are affected by delirium more than other demographics, therefore the benefits to this group would be the greatest in terms of decreasing morbidity and mortality.

White/pink noise was first described as a successful sleep intervention more than 30 years ago in a cardiac intensive care unit study. From that time to present there have been many studies that describe positive effects on sleep by noise machines as a single intervention, but typically they are bundled with other interventions such as earplugs and eye masks. Within the last 5 years, there has been a resurgence in the clinical study of white/pink noise on sleep quality and many of these studies use the gold standard of polysomnography, which employs many sensors to continuously monitor brain waves and sleep patterns. These studies also show a positive impact on both duration and quality of sleep.

More than 15 recent studies were identified that found a correlation between the sleep cycle and delirium. In these studies, sleep disturbance is present in the majority of patients with delirium. There is a clear link between sleep-wake cycle disturbance and delirium, but it is unclear whether an interrupted sleep-wake cycle causes delirium or vice versa. Despite the uncertainty, studies do show that sleep-enhancing interventions decrease rates of delirium and the duration of the delirium. The principal investigator would like to determine if white/pink noise can improve sleep quality and/or quantity, thereby decreasing the incidence of delirium.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • UAB Highlands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• English-speaking
• 65 years of age or older
• have an estimated hospital stay of 3 or more nights
• have no known hearing deficits or wear hearing aids
• be free of delirium on admission
• be legally able to consent

Exclusion Criteria:

• non-English-speaking
• less than 65 years of age
• have known hearing deficits or wear hearing aids
• have delirium on admission
• cannot legally consent to participation
• transferred to/from the ICU before/during being enrolled in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; The PI will set up the PicTek white/pink noise machine on the bedside table, and it will automatically turn on at 2200 and off at 0700 to the patient's preferred sound. The staff nurses will chart Nu-DESC scores every shift and as needed for change in mental status as is the current policy. The PI will collect Nu-DESC scores for the duration of the participants' hospital stays, age, race, gender, presence of a dementia diagnosis, and use of a pharmacological sleep aid.	Device: White/Pink Noise; White and/or pink noise will be played from 2200 to 0700 using the PicTek® white noise machine.
OTHER: Control Group; The PI will perform a chart review of patients who were admitted the month prior to the intervention being implemented. The PI will collect Nu-DESC scores for the duration of the participants' hospital stays, age, race, gender, presence of a dementia diagnosis, and use of a pharmacological sleep aid. These patients will receive the standard of care for delirium prevention.	Other: Control Group; Standard of care including lights on during the day and off at night, getting the patient out of bed for meals, presence of a large wall clock in the room, updating the whiteboard with current day, consistent reorientation of patient, geriatrician consults as needed, and pain management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nursing Delirium Screening Scale (Nu-DESC) Score	Nursing Delirium Screening Scale (Nu-DESC) scores, which are already routinely charted by staff nurses, will be collected after the PI sets up the white/pink noise intervention. A score of >2 is indicative of delirium.	Collected every 12-hours shift and as needed for acute change in mental status from baseline through discharge for a minimum of 3 nights not to exceed 14 days.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Latricia D Weed, PhD, Troy University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): December 8, 2018
• Study Completion (ACTUAL): December 8, 2018

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (ACTUAL): April 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: delirium; white noise; pink noise
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: IRB-300001385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available at this time since this is a small study. The protocol can be made available to other researchers at their request without the inclusion of IPD ensuring participant privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No