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Clinical Trials/NCT03755011
NCT03755011
Completed
Not Applicable

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

Yale University1 site in 1 country7 target enrollmentNovember 27, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Deprivation
Sponsor
Yale University
Enrollment
7
Locations
1
Primary Endpoint
Intervention fidelity: percent of intervention time during which white noise is actually delivered
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 27, 2018
End Date
March 15, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 48 hours

percent of intervention time during which white noise is actually delivered

Secondary Outcomes

  • Sound Levels(48 hours)
  • Sleep Questionnaire: Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires.(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.(48 hours)
  • Patient acceptance: percent of patients or surrogates who agree to receive white noise at night(48 hours)
  • Patient tolerance: percent of days that patients agree to continue white noise(48 hours)

Study Sites (1)

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