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

Yale University7 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Sleep Deprivation

Interventions

white noiseDEVICE

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.

usual careBEHAVIORAL

normal ICU activity noise

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Yale New Haven Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Intervention fidelity: percent of intervention time during which white noise is actually delivered

percent of intervention time during which white noise is actually delivered

Time frame: 48 hours

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 48 hours

Patient tolerance: percent of days that patients agree to continue white noise

percent of days that patients agree to continue white noise

Time frame: 48 hours

Patient acceptance: percent of patients or surrogates who agree to receive white noise at night

Data from ClinicalTrials.gov

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