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Completed

NCT Number: NCT03755011

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

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

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Key information

Conditions

Sleep Deprivation Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

white noise

Device

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 Care

Behavioral

normal ICU activity noise

Primary outcomes

  1. 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

  1. Sound Levels

    Time frame: 48 hours

    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).

  2. Sleep Questionnaire: Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires.

    Time frame: 48 hours

    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.

  3. 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.

    Time frame: 48 hours

    Patients will wear Actiwatch Spectrum devices to measure rest-activity patterns. Sleep will be identified using Actiwatch Software as provided by the manufacture.

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

    Time frame: 48 hours

    percent of days that patients agree to continue white noise

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

    Time frame: 48 hours

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2018
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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