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

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

Detailed Description
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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.

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

Conditions
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Sleep Deprivation

Intervention / Treatment
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* Device: white noise
* Behavioral: usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients exposed to white noise<br>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<br>* 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.<br>|
| Placebo Comparator: usual care<br>Six patients exposed to normal ICU activity noise. | Behavioral: usual care<br>* normal ICU activity noise<br>|

What is the study measuring?
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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 |