<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/NCT03019133</url>
  </required_header>
  <id_info>
    <org_study_id>201609843</org_study_id>
    <nct_id>NCT03019133</nct_id>
  </id_info>
  <brief_title>Trial to Evaluate the Effects of Sound Modulation on Critically Ill Patients</brief_title>
  <acronym>SMART</acronym>
  <official_title>Prospective Randomized Controlled Trial to Compare and Analyze the Effects of Sound Masking and Reduction Techniques on Heart Rate and Blood Pressure Variability in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brian Gehlbach</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the project is to determine the effects of noise masking and noise reduction on&#xD;
      stress related physiological parameters in critically ill patients admitted to the intensive&#xD;
      care unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sleep deprivation is common in critically ill patients in the intensive care unit (ICU) and&#xD;
      may impair recovery. While noise is widely cited as the most common cause of sleep disruption&#xD;
      in the ICU setting, its contribution to sympathetic activity in critically ill patients is&#xD;
      not known. This is an important knowledge gap, because noise initiates a sequence of&#xD;
      physiological changes including vasoconstriction, raised diastolic blood pressure, pupil&#xD;
      dilatation and muscle tension. Furthermore, noise is implicated in sympathetic arousals,&#xD;
      resulting in a release of adrenaline which prevents relaxation and consequently prevents the&#xD;
      patient from falling asleep.&#xD;
&#xD;
      The investigators plan to study the effect of noise masking and noise reduction on stress&#xD;
      related physiological parameters in critically ill patients admitted to the ICU. Subjects&#xD;
      will be randomized into 3 separate groups: control, noise reduction, and noise masking. The&#xD;
      investigators will compare the heart rate and blood pressure variability between and within&#xD;
      the groups to determine the effects of treatment assignment on these variables. Non-invasive&#xD;
      measurements obtained from the bedside monitor will be collected using physiological data&#xD;
      acquisition software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nocturnal LF/HF ratio (a.u.)</measure>
    <time_frame>Day 1 of study</time_frame>
    <description>The effect of group assignment on nocturnal (8pm to 8am) low frequency/high frequency (LF/HF) ratio will be determined.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nocturnal heart rate (bpm)</measure>
    <time_frame>Day 1 of study</time_frame>
    <description>The effect of group assignment on nocturnal (8pm to 8am) heart rate will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nocturnal RMSSD (ms)</measure>
    <time_frame>Day 1 of study</time_frame>
    <description>The effect of group assignment on nocturnal (8pm to 8am) root mean square of sequential differences of RR intervals (RMSSD) will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nocturnal blood pressure (mm Hg)</measure>
    <time_frame>Day 1 of study</time_frame>
    <description>The effect of group assignment on nocturnal (8pm to 8am) blood pressure (mean arterial pressure) will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of ICU delirium</measure>
    <time_frame>Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment</time_frame>
    <description>The effect of group assignment on the incidence of ICU delirium as assessed by the CAM-ICU will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay (days)</measure>
    <time_frame>Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.</time_frame>
    <description>The effect of group assignment on hospital length of stay will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay (days)</measure>
    <time_frame>Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment.</time_frame>
    <description>The effect of group assignment on ICU length of stay will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality (%)</measure>
    <time_frame>Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.</time_frame>
    <description>The effect of group assignment on in-hospital mortality will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharged home (%, versus discharge to another health care facility or died)</measure>
    <time_frame>Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.</time_frame>
    <description>The effect of group assignment on being discharged directly to home (versus to another skilled care facility or died) from the hospital will be assessed.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Intra-individual nocturnal LF/HF ratio (a.u.)</measure>
    <time_frame>Days 1 and 2 of study</time_frame>
    <description>For each subject, the effect of treatment assignment on nocturnal (8pm to 8am) low frequency/high frequency (LF/HF) ratio will be determined by comparing the LF/HF ratio on Day 1 (intervention) with that on Day 2.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Critical Illness</condition>
  <condition>Physiological Stress</condition>
  <condition>Delirium</condition>
  <condition>Sleep Deprivation</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care will be provided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sound reduction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of noise reduction headphones. Pro For Sho safety ear muffs with a noise reduction rate of 34dB will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sound masking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of headphones and relaxing music. Sennheiser HD 280 pro headphones will be used for sound masking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sound reduction</intervention_name>
    <description>Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am.</description>
    <arm_group_label>Sound reduction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sound masking</intervention_name>
    <description>Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am.</description>
    <arm_group_label>Sound masking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 18-99 years who are expected to receive care on an adult critical care&#xD;
             unit for at least 24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Admission for drug overdose or with a known substance abuse disorder&#xD;
&#xD;
          -  Untreated sleep apnea disorder, narcolepsy, REM sleep behavior disorder, parasomnia,&#xD;
             restless leg syndrome or other sleep disorder&#xD;
&#xD;
          -  Use of hearing aids, or known significant conductive or sensory hearing loss&#xD;
&#xD;
          -  Ventilator support via an endotracheal tube&#xD;
&#xD;
          -  Use of vasopressors&#xD;
&#xD;
          -  Unresponsive or delirious&#xD;
&#xD;
          -  Subjects with known Dementia, Parkinson's disease, or other neurodegenerative disorder&#xD;
&#xD;
          -  Subjects with a pacemaker or who have received cardiac transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian K Gehlbach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brian K Gehlbach, MD</last_name>
    <phone>319-356-3603</phone>
    <email>brian-gehlbach@uiowa.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brian K Gehlbach, MD</last_name>
      <phone>319-356-3603</phone>
      <email>brian-gehlbach@uiowa.edu</email>
    </contact>
    <investigator>
      <last_name>Brian K Gehlbach, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Brian Gehlbach</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Heart rate</keyword>
  <keyword>Blood pressure variability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>As this is a pilot study, there are no definite plans for sharing individual participant data at this time.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>201609843</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>http://hawkirb.research.uiowa.edu</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03019133
org study id: 201609843
nct id: NCT03019133
lead sponsor: 
has dmc: No
The goal of the project is to determine the effects of noise masking and noise reduction on
      stress related physiological parameters in critically ill patients admitted to the intensive
      care unit.
Sleep deprivation is common in critically ill patients in the intensive care unit (ICU) and
      may impair recovery. While noise is widely cited as the most common cause of sleep disruption
      in the ICU setting, its contribution to sympathetic activity in critically ill patients is
      not known. This is an important knowledge gap, because noise initiates a sequence of
      physiological changes including vasoconstriction, raised diastolic blood pressure, pupil
      dilatation and muscle tension. Furthermore, noise is implicated in sympathetic arousals,
      resulting in a release of adrenaline which prevents relaxation and consequently prevents the
      patient from falling asleep.

      The investigators plan to study the effect of noise masking and noise reduction on stress
      related physiological parameters in critically ill patients admitted to the ICU. Subjects
      will be randomized into 3 separate groups: control, noise reduction, and noise masking. The
      investigators will compare the heart rate and blood pressure variability between and within
      the groups to determine the effects of treatment assignment on these variables. Non-invasive
      measurements obtained from the bedside monitor will be collected using physiological data
      acquisition software.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Nocturnal LF/HF ratio (a.u.)
time frame: Day 1 of study
description: The effect of group assignment on nocturnal (8pm to 8am) low frequency/high frequency (LF/HF) ratio will be determined.
measure: Nocturnal heart rate (bpm)
time frame: Day 1 of study
description: The effect of group assignment on nocturnal (8pm to 8am) heart rate will be determined.
measure: Nocturnal RMSSD (ms)
time frame: Day 1 of study
description: The effect of group assignment on nocturnal (8pm to 8am) root mean square of sequential differences of RR intervals (RMSSD) will be determined.
measure: Nocturnal blood pressure (mm Hg)
time frame: Day 1 of study
description: The effect of group assignment on nocturnal (8pm to 8am) blood pressure (mean arterial pressure) will be determined.
measure: Incidence of ICU delirium
time frame: Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment
description: The effect of group assignment on the incidence of ICU delirium as assessed by the CAM-ICU will be determined.
measure: Hospital length of stay (days)
time frame: Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.
description: The effect of group assignment on hospital length of stay will be assessed.
measure: ICU length of stay (days)
time frame: Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment.
description: The effect of group assignment on ICU length of stay will be assessed.
measure: Hospital mortality (%)
time frame: Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.
description: The effect of group assignment on in-hospital mortality will be assessed.
measure: Discharged home (%, versus discharge to another health care facility or died)
time frame: Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.
description: The effect of group assignment on being discharged directly to home (versus to another skilled care facility or died) from the hospital will be assessed.
measure: Intra-individual nocturnal LF/HF ratio (a.u.)
time frame: Days 1 and 2 of study
description: For each subject, the effect of treatment assignment on nocturnal (8pm to 8am) low frequency/high frequency (LF/HF) ratio will be determined by comparing the LF/HF ratio on Day 1 (intervention) with that on Day 2.
arm group label: Usual Care
arm group type: No Intervention
description: Usual care will be provided.
arm group label: Sound reduction
arm group type: Active Comparator
description: Use of noise reduction headphones. Pro For Sho safety ear muffs with a noise reduction rate of 34dB will be used.
arm group label: Sound masking
arm group type: Active Comparator
description: Use of headphones and relaxing music. Sennheiser HD 280 pro headphones will be used for sound masking.
intervention type: Device
intervention name: Sound reduction
description: Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am.
arm group label: Sound reduction
intervention type: Device
intervention name: Sound masking
description: Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am.
arm group label: Sound masking
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Brian K Gehlbach, MD
role: Principal Investigator
affiliation: Faculty
last name: Brian K Gehlbach, MD
phone: 319-356-3603
email: brian-gehlbach@uiowa.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Brian Gehlbach
investigator title: Clinical Associate Professor
mesh term: Sleep Deprivation
mesh term: Critical Illness
sharing ipd: No
ipd description: As this is a pilot study, there are no definite plans for sharing individual participant data at this time.
study doc: 