<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/NCT03774212</url>
  </required_header>
  <id_info>
    <org_study_id>AC18134</org_study_id>
    <nct_id>NCT03774212</nct_id>
  </id_info>
  <brief_title>Sleep Headphones and HDU: a Novel Intervention and Sound Evaluation</brief_title>
  <acronym>SHH: Noise!</acronym>
  <official_title>Do Active Noise Cancelling Headphones With White Noise Masking Improve Sleep in Non-ventilated, Non-delirious Critical Care Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Lothian</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is well established that patients sleep poorly in the Intensive Care Unit (ICU), and&#xD;
      excessive noise is considered to be a modifiable cause of this. Previous studies have tried&#xD;
      to reduce ambient noise by educating staff and fixing noisy equipment. Other studies have&#xD;
      tried to reduce the noise experienced by patients by supplying them with active noise&#xD;
      cancelling headphones and earplugs. In this study we are combining Active Noise Cancelling&#xD;
      headphones with white noise to try and reduce noise experienced by patients, with the aim of&#xD;
      improving their sleep. Sleep deprivation is known to negatively impact health, and so&#xD;
      improving sleep may improve patient outcomes as well as improve the patient's experience in&#xD;
      critical care.&#xD;
&#xD;
      The Investigators will screen all patients in the critical care wards in the Royal Infirmary&#xD;
      of Edinburgh. Patients that are receiving ventilation, are delirious or have already been&#xD;
      enrolled in the study will be excluded. After allowing patients to give informed consent, we&#xD;
      will randomise them into one of two study groups:&#xD;
&#xD;
      Study group A will receive standard care on the 1st night (no headphones), and will receive&#xD;
      the intervention (active noise cancelling headphones with white noise) on the 2nd night.&#xD;
&#xD;
      Study group B will receive the intervention on the 1st night, and will receive standard care&#xD;
      on the 2nd night.&#xD;
&#xD;
      All patients will wear a Xiaomi MiBand 2 wrist band, that tracks movement and sleep.&#xD;
&#xD;
      Patients will fill in the Pittsburgh Sleep Quality Index at the beginning of the study to&#xD;
      establish usual sleeping habits.&#xD;
&#xD;
      Our primary outcome measure is the mean score on the Richard Campbell Sleep Questionnaire&#xD;
      (RCSQ), which will be filled in by the patient the morning after each night.&#xD;
&#xD;
      Our secondary outcome measure is the data from the wrist band, noise levels measured&#xD;
      overnight, and patient experience of the intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 18, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in score on the Richards-Campbell sleep questionnaire.</measure>
    <time_frame>Day 1 and day 2 after participant's enrolment. Completed throughout the 6 month study duration.</time_frame>
    <description>Richards-Campbell sleep questionnaire is a series of 5 Visual analog scales that are 100mm long, and range from &quot;best possible&quot; to &quot;worst possible&quot;. The final result is calculated by taking a mean of the distances along each line (from left to right).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient experience</measure>
    <time_frame>Day 2 after participant's enrolment. Completed throughout the 6 month study duration.</time_frame>
    <description>Patients will fill out a questionnaire about their experience. Participants will be required to circle an appropriate descriptive word to answer each question.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actigraphy data</measure>
    <time_frame>Night 1 and 2 of participant's enrolment. Completed throughout the 6 month study duration.</time_frame>
    <description>The wrist band provides:&#xD;
Total sleep time&#xD;
Deep sleep time&#xD;
Light sleep Time</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Sleep Deprivation</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On study night 1, participants will receive standard care (no headphones provided). On study night 2, these patients will wear Active Noise Cancelling headphones playing white noise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will spend night 1 wearing Active Noise Cancelling headphones playing white noise. On Study night 2, these patients will receive standard care (no headphones provided).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active noise cancelling headphones</intervention_name>
    <description>The white noise will play from an 'iPod touch' (Apple), through the active noise cancelling headphones.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <other_name>White noise masking</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Critical care patient in Royal Infirmary of Edinburgh&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  If the patient is delirious. This will be clarified by asking the nurses, who use the&#xD;
             Confusion Assessment method for the ICU (CAM-ICU) Score.&#xD;
&#xD;
          -  If the patient is receiving any form of ventilation (invasive or non-invasive&#xD;
             ventilation, continuous positive airway pressure (CPAP), High flow nasal oxygen (HFNO)&#xD;
             or respiratory support at night)&#xD;
&#xD;
          -  Physical reasons why they can't wear over-ear headphones&#xD;
&#xD;
          -  Pre-existing severe hearing impairment&#xD;
&#xD;
          -  Previous participation in the study.&#xD;
&#xD;
          -  If the patient is likely to receive medical interventions during the night that would&#xD;
             disturb their sleep.&#xD;
&#xD;
          -  Patients expected to leave the critical care wards within the following 48hours.&#xD;
&#xD;
          -  Refusing consent or inability to give consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Royal Infirmary of Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>August 9, 2019</last_update_submitted>
  <last_update_submitted_qc>August 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Critical care patients</keyword>
  <keyword>High dependency unit</keyword>
  <keyword>Intensive care unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will not be sharing individual participant data with other researchers</ipd_description>
  </patient_data>
  <!-- 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/NCT03774212
org study id: AC18134
nct id: NCT03774212
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is well established that patients sleep poorly in the Intensive Care Unit (ICU), and
      excessive noise is considered to be a modifiable cause of this. Previous studies have tried
      to reduce ambient noise by educating staff and fixing noisy equipment. Other studies have
      tried to reduce the noise experienced by patients by supplying them with active noise
      cancelling headphones and earplugs. In this study we are combining Active Noise Cancelling
      headphones with white noise to try and reduce noise experienced by patients, with the aim of
      improving their sleep. Sleep deprivation is known to negatively impact health, and so
      improving sleep may improve patient outcomes as well as improve the patient's experience in
      critical care.

      The Investigators will screen all patients in the critical care wards in the Royal Infirmary
      of Edinburgh. Patients that are receiving ventilation, are delirious or have already been
      enrolled in the study will be excluded. After allowing patients to give informed consent, we
      will randomise them into one of two study groups:

      Study group A will receive standard care on the 1st night (no headphones), and will receive
      the intervention (active noise cancelling headphones with white noise) on the 2nd night.

      Study group B will receive the intervention on the 1st night, and will receive standard care
      on the 2nd night.

      All patients will wear a Xiaomi MiBand 2 wrist band, that tracks movement and sleep.

      Patients will fill in the Pittsburgh Sleep Quality Index at the beginning of the study to
      establish usual sleeping habits.

      Our primary outcome measure is the mean score on the Richard Campbell Sleep Questionnaire
      (RCSQ), which will be filled in by the patient the morning after each night.

      Our secondary outcome measure is the data from the wrist band, noise levels measured
      overnight, and patient experience of the intervention.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in score on the Richards-Campbell sleep questionnaire.
time frame: Day 1 and day 2 after participant's enrolment. Completed throughout the 6 month study duration.
description: Richards-Campbell sleep questionnaire is a series of 5 Visual analog scales that are 100mm long, and range from "best possible" to "worst possible". The final result is calculated by taking a mean of the distances along each line (from left to right).
measure: Patient experience
time frame: Day 2 after participant's enrolment. Completed throughout the 6 month study duration.
description: Patients will fill out a questionnaire about their experience. Participants will be required to circle an appropriate descriptive word to answer each question.
measure: Actigraphy data
time frame: Night 1 and 2 of participant's enrolment. Completed throughout the 6 month study duration.
description: The wrist band provides:
Total sleep time
Deep sleep time
Light sleep Time
arm group label: Group A
arm group type: Experimental
description: On study night 1, participants will receive standard care (no headphones provided). On study night 2, these patients will wear Active Noise Cancelling headphones playing white noise.
arm group label: Group B
arm group type: Experimental
description: Patients will spend night 1 wearing Active Noise Cancelling headphones playing white noise. On Study night 2, these patients will receive standard care (no headphones provided).
intervention type: Device
intervention name: Active noise cancelling headphones
description: The white noise will play from an 'iPod touch' (Apple), through the active noise cancelling headphones.
arm group label: Group A
arm group label: Group B
other name: White noise masking
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Sleep Deprivation
sharing ipd: No
ipd description: We will not be sharing individual participant data with other researchers