White Noise to Improve Sleep in the Medical Intensive Care Unit (MICU): a Pilot and Feasibility Study

White Noise to Improve Sleep in the MICU: a Pilot and Feasibility Study

A feasibility study to evaluate the use of white noise to improve sleeping conditions in an ICU setting.

Study Overview

• Status: Completed
• Conditions: Sleep Deprivation
• Intervention / Treatment: Device: white noise; Behavioral: usual care

Detailed Description

The ICU is full of alarms and critically ill patients, so it is no surprise that sleep is very much fragmented and poor in this setting, as documented in numerous studies. White noise is a simple intervention that has been shown to improve sleep, including in the ICU setting. The aim is to conduct a pilot trial evaluating the feasibility of providing white noise to patients in the ICU at night to help improve sleep. The plan to measure feasibility metrics including patient acceptance, patient tolerance, and intervention fidelity; also to seek feedback from patients, nurses, and providers. Secondly is to evaluate the benefits of providing white noise at night in the ICU on sleep as measured by actigraphy and Richards-Campbell Sleep Questionnaires and total room sound.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults >18yo admitted to MICU with expected stay of at least two nights after enrollment

Exclusion Criteria:

• Excluding intubated patients (so communication can be better) and patients on high-flow nasal cannula (which is already high background noise).
• Patients who are on therapeutic hypothermia or are on comfort measures only will also be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients exposed to white noise; Six patients in the interventional arm will have white noise (through in-room workstations- on-wheels and publicly-available white noise websites) playing overnight at a standardized volume to be determined; pausing will be at nurse, provider, and patient discretion during routine care and conversations with the patients.	Device: white noise; Patients in the interventional arm will have white noise (through in-room workstations- on-wheels and publicly-available white noise websites) playing overnight at a standardized volume to be determined.
Placebo Comparator: usual care; Six patients exposed to normal ICU activity noise.	Behavioral: usual care; normal ICU activity noise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention fidelity: percent of intervention time during which white noise is actually delivered	percent of intervention time during which white noise is actually delivered	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sound Levels	Room dBA and dBC-weighted sound levels will be measured in the rooms as well by HD600 sound meters (Extech Instruments) every 10 seconds throughout the night shift; sound meters will be placed on the wall behind and 10" above the head of the bed (set when head of bed is at 30 degrees).	48 hours
Sleep Questionnaire: Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires.	Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires. Scores will be graded on a scale of 0-100, as measured in mm on the visual scale; 100 representing a more positive sleep experience.	48 hours
Actigraphic rest-activity :Patients will wear Actiwatch Spectrum devices to measure rest-activity patterns. Sleep will be identified using Actiwatch Software as provided by the manufacture.	Patients will wear Actiwatch Spectrum devices to measure rest-activity patterns. Sleep will be identified using Actiwatch Software as provided by the manufacture.	48 hours
Patient tolerance: percent of days that patients agree to continue white noise	percent of days that patients agree to continue white noise	48 hours
Patient acceptance: percent of patients or surrogates who agree to receive white noise at night	percent of patients or surrogates who agree to receive white noise at night	48 hours

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Catherine Gao, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation
• Other Study ID Numbers: 2000024300

Drug and device information, study documents

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