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

Primary Purpose

Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
white noise
usual care
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Deprivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

patients exposed to white noise

usual care

Arm Description

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.

Six patients exposed to normal ICU activity noise.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 26, 2018
Last Updated
March 29, 2019
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03755011
Brief Title
White Noise to Improve Sleep in the Medical Intensive Care Unit (MICU): a Pilot and Feasibility Study
Official Title
White Noise to Improve Sleep in the MICU: a Pilot and Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients exposed to white noise
Arm Type
Experimental
Arm Description
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.
Arm Title
usual care
Arm Type
Placebo Comparator
Arm Description
Six patients exposed to normal ICU activity noise.
Intervention Type
Device
Intervention Name(s)
white noise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
normal ICU activity noise
Primary Outcome Measure Information:
Title
Intervention fidelity: percent of intervention time during which white noise is actually delivered
Description
percent of intervention time during which white noise is actually delivered
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Sound Levels
Description
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
Title
Sleep Questionnaire: Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires.
Description
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
Title
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.
Description
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
Title
Patient tolerance: percent of days that patients agree to continue white noise
Description
percent of days that patients agree to continue white noise
Time Frame
48 hours
Title
Patient acceptance: percent of patients or surrogates who agree to receive white noise at night
Description
percent of patients or surrogates who agree to receive white noise at night
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Gao, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

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

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