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

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755011
• Other study ID #: 2000024300
• Status: Completed
• Phase: N/A
• Start date: November 27, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: March 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

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.

Behavioral:
• usual care
normal ICU activity noise

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Patient tolerance: percent of days that patients agree to continue white noise	percent of days that patients agree to continue white noise	48 hours
Secondary	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