<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/NCT03757897</url>
  </required_header>
  <id_info>
    <org_study_id>2000024166</org_study_id>
    <nct_id>NCT03757897</nct_id>
  </id_info>
  <brief_title>The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics.</brief_title>
  <official_title>The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics&#xD;
      and mechanical properties of brain tissue at two states of arousal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics&#xD;
      and mechanical properties of brain tissue at two states of arousal:&#xD;
&#xD;
        1. Resting, awake state&#xD;
&#xD;
        2. During sleep with low-dose intravenous infusion of dexmedetomidine (titrated to a&#xD;
           Bispectral index (BIS) of 60-70)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The investigators were unable to implement a MRI compatible EEG for use in human subjects&#xD;
    (equipment and technical issues).&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a preliminary interventional trial in which participants will serve as their own controls.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CSF volume increase by 10%</measure>
    <time_frame>2 hours 30 minutes</time_frame>
    <description>We hypothesize that CSF volume (as measured by T1 relaxation) will expand by 10% with DEXM- induced sleep compared to wakefulness. The increase in CSF volume during DEXM-induced sleep occurs because DEXM lowers central norepinephrine tone and sleep causes an increase in the interstitial fluid (ISF) volume (cell volume shrinks). MRI will take place 30 minutes after dexmedetomidine infusion.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cerebrospinal Fluid Pressure Increased</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine induced sleep patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will be measured for CSF volume, diffusion parameters and mechanical 'stiffness' of the brain during wakefulness and during sleep-induced with dexmedetomidine (DEXM).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>The standard dosing of 1mcg/kg will be implemented over 10 minutes followed by a maintenance infusion of 0.2-1.0 titrated to a the target BIS (60-70) during the 20 minutes prior to MRI.</description>
    <arm_group_label>Dexmedetomidine induced sleep patients</arm_group_label>
    <other_name>DEXM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy Males or females between 18 and 40 years of age. Determined to be American&#xD;
             Society of Anesthesiologist (ASA) 1 subjects.&#xD;
&#xD;
          2. Ability to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with potential difficult airway as determined by the anesthesiologist&#xD;
&#xD;
          2. History of or family history of difficulty with anesthesia or sedation procedures&#xD;
&#xD;
          3. Known intolerance to dexmedetomidine&#xD;
&#xD;
          4. Body mass index &gt;30&#xD;
&#xD;
          5. Subjects with any of the following: narcolepsy, obstructive sleep apnea (OSA) and/or&#xD;
             abnormal sleeping patterns (including but not limited to those who use a Continuous&#xD;
             positive Airway Pressure (C-PAP) machine, sleeping during the day, using medication to&#xD;
             fall asleep, subjects reporting snoring as determined by self- report using Snoring,&#xD;
             Tiredness, Observed apnea, Blood pressure, Body mass index, Age, Neck circumference&#xD;
             and Gender (STOP-BANG) questionnaire (i) for undiagnosed OSA (3 or more 'yes' answers&#xD;
             will exclude) and/or medical history;&#xD;
&#xD;
          6. Subjects with a history of restless leg syndrome as determined by self-report and/or&#xD;
             medical history;&#xD;
&#xD;
          7. Use, in the past two weeks, of psychoactive medications (four weeks for fluoxetine) or&#xD;
             medications that may affect brain function (including but not limited to opioid&#xD;
             analgesics, antidepressants, antipsychotics, benzodiazepines and barbiturates) as&#xD;
             determined by self-report and/or medical history;&#xD;
&#xD;
          8. Current or past Diagnostic and Statistical Manual of Mental Disorders (DSM-V)&#xD;
             diagnosis of a psychiatric disorder if it was severe enough to require the use of&#xD;
             medications and or hospitalization to treat the condition.&#xD;
&#xD;
          9. Major medical problems that can impact brain function (e.g., problems of the Central&#xD;
             Nervous System including seizures and psychosis; cardiovascular disease including&#xD;
             hypertension and arrhythmias; metabolic, autoimmune, endocrine disorders) as&#xD;
             determined by self-report, medical history and/or clinical exam;&#xD;
&#xD;
         10. Hepatic dysfunction or impairment as determined by subjects' self-reported history&#xD;
&#xD;
         11. Head trauma with loss of consciousness for more than 60 minutes as determined by&#xD;
             self-report and/or medical history;&#xD;
&#xD;
         12. Positive urine test for controlled substances (cocaine, methamphetamine, amphetamines,&#xD;
             opioids, cannabinoids, benzodiazepines and barbiturates) at the screening visit and at&#xD;
             each visit of imaging study and neuropsychological assessment;&#xD;
&#xD;
         13. Positive urine pregnancy test;&#xD;
&#xD;
         14. Nursing mothers will be excluded&#xD;
&#xD;
         15. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the&#xD;
             head (including but not limited to pacemakers or other implanted electrical devices,&#xD;
             brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses,&#xD;
             permanent eyeliner, large tattoos, implanted delivery pump, or shrapnel fragments) or&#xD;
             fear of enclosed spaces as determined by the self-report checklist.&#xD;
&#xD;
         16. Fear of enclosed spaces (claustrophobia) as determined by self-report and medical&#xD;
             history.&#xD;
&#xD;
         17. Cannot lie comfortably flat on the back for up to 3 hours in the MRI scanner as&#xD;
             determined by self- report.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helene Benveniste, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dexmedetomidine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_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/NCT03757897
org study id: 2000024166
nct id: NCT03757897
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics
      and mechanical properties of brain tissue at two states of arousal.
The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics
      and mechanical properties of brain tissue at two states of arousal:

        1. Resting, awake state

        2. During sleep with low-dose intravenous infusion of dexmedetomidine (titrated to a
           Bispectral index (BIS) of 60-70)
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a preliminary interventional trial in which participants will serve as their own controls.
primary purpose: Diagnostic
masking: None (Open Label)
measure: CSF volume increase by 10%
time frame: 2 hours 30 minutes
description: We hypothesize that CSF volume (as measured by T1 relaxation) will expand by 10% with DEXM- induced sleep compared to wakefulness. The increase in CSF volume during DEXM-induced sleep occurs because DEXM lowers central norepinephrine tone and sleep causes an increase in the interstitial fluid (ISF) volume (cell volume shrinks). MRI will take place 30 minutes after dexmedetomidine infusion.
arm group label: Dexmedetomidine induced sleep patients
arm group type: Experimental
description: All subjects will be measured for CSF volume, diffusion parameters and mechanical 'stiffness' of the brain during wakefulness and during sleep-induced with dexmedetomidine (DEXM).
intervention type: Drug
intervention name: Dexmedetomidine
description: The standard dosing of 1mcg/kg will be implemented over 10 minutes followed by a maintenance infusion of 0.2-1.0 titrated to a the target BIS (60-70) during the 20 minutes prior to MRI.
arm group label: Dexmedetomidine induced sleep patients
other name: DEXM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Helene Benveniste, MD, PhD
role: Principal Investigator
affiliation: Yale University
responsible party type: Sponsor
mesh term: Intracranial Hypertension
mesh term: Dexmedetomidine