<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03755011</url>
  </required_header>
  <id_info>
    <org_study_id>2000024300</org_study_id>
    <nct_id>NCT03755011</nct_id>
  </id_info>
  <brief_title>White Noise to Improve Sleep in the Medical Intensive Care Unit (MICU): a Pilot and Feasibility Study</brief_title>
  <official_title>White Noise to Improve Sleep in the MICU: a Pilot and Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A feasibility study to evaluate the use of white noise to improve sleeping conditions in an&#xD;
      ICU setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ICU is full of alarms and critically ill patients, so it is no surprise that sleep is&#xD;
      very much fragmented and poor in this setting, as documented in numerous studies. White noise&#xD;
      is a simple intervention that has been shown to improve sleep, including in the ICU setting.&#xD;
      The aim is to conduct a pilot trial evaluating the feasibility of providing white noise to&#xD;
      patients in the ICU at night to help improve sleep. The plan to measure feasibility metrics&#xD;
      including patient acceptance, patient tolerance, and intervention fidelity; also to seek&#xD;
      feedback from patients, nurses, and providers. Secondly is to evaluate the benefits of&#xD;
      providing white noise at night in the ICU on sleep as measured by actigraphy and&#xD;
      Richards-Campbell Sleep Questionnaires and total room sound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Actual">March 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intervention fidelity: percent of intervention time during which white noise is actually delivered</measure>
    <time_frame>48 hours</time_frame>
    <description>percent of intervention time during which white noise is actually delivered</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sound Levels</measure>
    <time_frame>48 hours</time_frame>
    <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&quot; above the head of the bed (set when head of bed is at 30 degrees).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Questionnaire: Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires.</measure>
    <time_frame>48 hours</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>48 hours</time_frame>
    <description>Patients will wear Actiwatch Spectrum devices to measure rest-activity patterns. Sleep will be identified using Actiwatch Software as provided by the manufacture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient tolerance: percent of days that patients agree to continue white noise</measure>
    <time_frame>48 hours</time_frame>
    <description>percent of days that patients agree to continue white noise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient acceptance: percent of patients or surrogates who agree to receive white noise at night</measure>
    <time_frame>48 hours</time_frame>
    <description>percent of patients or surrogates who agree to receive white noise at night</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Sleep Deprivation</condition>
  <arm_group>
    <arm_group_label>patients exposed to white noise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Six patients exposed to normal ICU activity noise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>white noise</intervention_name>
    <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.</description>
    <arm_group_label>patients exposed to white noise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>usual care</intervention_name>
    <description>normal ICU activity noise</description>
    <arm_group_label>usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults &gt;18yo admitted to MICU with expected stay of at least two nights after&#xD;
             enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Excluding intubated patients (so communication can be better) and patients on&#xD;
             high-flow nasal cannula (which is already high background noise).&#xD;
&#xD;
          -  Patients who are on therapeutic hypothermia or are on comfort measures only will also&#xD;
             be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine Gao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>March 29, 2019</last_update_submitted>
  <last_update_submitted_qc>March 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03755011
org study id: 2000024300
nct id: NCT03755011
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A feasibility study to evaluate the use of white noise to improve sleeping conditions in an
      ICU setting.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Intervention fidelity: percent of intervention time during which white noise is actually delivered
time frame: 48 hours
description: percent of intervention time during which white noise is actually delivered
measure: Sound Levels
time frame: 48 hours
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).
measure: 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
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.
measure: 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
description: Patients will wear Actiwatch Spectrum devices to measure rest-activity patterns. Sleep will be identified using Actiwatch Software as provided by the manufacture.
measure: Patient tolerance: percent of days that patients agree to continue white noise
time frame: 48 hours
description: percent of days that patients agree to continue white noise
measure: Patient acceptance: percent of patients or surrogates who agree to receive white noise at night
time frame: 48 hours
description: percent of patients or surrogates who agree to receive white noise at night
arm group label: patients exposed to white noise
arm group type: Experimental
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 group label: usual care
arm group type: Placebo Comparator
description: Six patients exposed to normal ICU activity noise.
intervention type: Device
intervention name: white noise
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.
arm group label: patients exposed to white noise
intervention type: Behavioral
intervention name: usual care
description: normal ICU activity noise
arm group label: usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine Gao, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Deprivation