<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/NCT03304652</url>
  </required_header>
  <id_info>
    <org_study_id>170804</org_study_id>
    <nct_id>NCT03304652</nct_id>
  </id_info>
  <brief_title>Cerebral MRI During Sleep</brief_title>
  <official_title>Cerebral MRI During Sleep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</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>
      Recent studies in animal models have suggested a critical role for cerebrospinal fluid and&#xD;
      Interstitial fluid flux through cerebral parenchyma for removal of byproducts of cellular&#xD;
      metabolism and hence in maintaining the health of the brain. This effect is modulated during&#xD;
      sleep, suggesting a potentially important mechanism for sleep to maintain both acute&#xD;
      homeostasis and long-term cerebral health.&#xD;
&#xD;
      The central goal of these studies is to develop a sensitive MRI biomarker of cerebral&#xD;
      conformational changes during sleep. This exploratory work aims to establish the sensitivity&#xD;
      and reproducibility of MRI as a non-invasive neuroimaging assessment of cerebral changes&#xD;
      during natural sleep and sedation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent studies in animal models have suggested a critical role for cerebrospinal fluid (CSF)&#xD;
      / Interstitial fluid (ISF) flux through cerebral parenchyma for removal of byproducts of&#xD;
      cellular metabolism and hence in maintaining the health of the brain. It remains unknown to&#xD;
      what extent these phenomena exist in the human brain. A key challenge in this work is to make&#xD;
      non-invasive and reproducible measurements of the cerebral microenvironment in humans. For&#xD;
      these studies, the investigators have implemented a suite of MRI measurements to track&#xD;
      physiological changes in the brain during sleep. This exploratory work aims to establish the&#xD;
      sensitivity and reproducibility of MRI as a non-invasive neuroimaging assessment of cerebral&#xD;
      changes during natural sleep and sedation. The long term goal of this work is to use MRI as&#xD;
      an imaging biomarker to assess the cerebral response to normal versus disordered sleep in&#xD;
      patients.&#xD;
&#xD;
      Our specific aims will address the following questions:&#xD;
&#xD;
      Aim 1: How sensitive are MRI metrics for determining changes in the brain during sleep?&#xD;
&#xD;
      Aim 2: How reproducible are MRI metrics during sleep and during sedation?&#xD;
&#xD;
      The investigators will recruit 12 normal adult subjects for this study (consecutive&#xD;
      respondees to recruitment adverts). The investigators will make regional MRI measurements&#xD;
      during onset, maintenance and waking from stage N2 sleep. From these the investigators will&#xD;
      characterize which MRI metrics are most sensitive to changes in the cerebral environment, and&#xD;
      how these vary for different cerebral regions.&#xD;
&#xD;
      Measurements will be repeated during ~90 minutes of natural sleep, and following oral&#xD;
      sedation with 10 mg zaleplon (Sonata).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cerebral MRI Changes</measure>
    <time_frame>90 Minutes of Sleep</time_frame>
    <description>Change in MRI Signal from Awake Baseline</description>
  </primary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Sleep</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zaleplon</intervention_name>
    <description>Sleep Aid; 10mg; Oral; Single Use</description>
    <other_name>Sonata</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Natural Sleep</intervention_name>
    <description>Natural Sleep without medication</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        12 normal adults for this study aged 18-59. Both male and female. Consecutive participant&#xD;
        sampling&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. age not in range 18-59&#xD;
&#xD;
          2. smoking / recreational drug use&#xD;
&#xD;
          3. pregnant women / breast feeding&#xD;
&#xD;
          4. contraindication to MRI&#xD;
&#xD;
          5. contraindications to Zaleplon&#xD;
&#xD;
          6. history of cardiovascular pulmonary or cerebral disease (hypertension (diastolic &gt;90&#xD;
             mmHg, systolic &gt; 150 mmHg), unstable cerebrovascular syndromes, prior history of&#xD;
             cardiac arrhythmias, unstable angina, chronic obstructive pulmonary disease).&#xD;
&#xD;
          7. Current SSRI antidepressant medication&#xD;
&#xD;
          8. History of sleep disorder or currently taking sedative / stimulant medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>UC San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093-0677</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>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>David Dubowitz</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zaleplon</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03304652
org study id: 170804
nct id: NCT03304652
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Recent studies in animal models have suggested a critical role for cerebrospinal fluid and
      Interstitial fluid flux through cerebral parenchyma for removal of byproducts of cellular
      metabolism and hence in maintaining the health of the brain. This effect is modulated during
      sleep, suggesting a potentially important mechanism for sleep to maintain both acute
      homeostasis and long-term cerebral health.

      The central goal of these studies is to develop a sensitive MRI biomarker of cerebral
      conformational changes during sleep. This exploratory work aims to establish the sensitivity
      and reproducibility of MRI as a non-invasive neuroimaging assessment of cerebral changes
      during natural sleep and sedation.
Recent studies in animal models have suggested a critical role for cerebrospinal fluid (CSF)
      / Interstitial fluid (ISF) flux through cerebral parenchyma for removal of byproducts of
      cellular metabolism and hence in maintaining the health of the brain. It remains unknown to
      what extent these phenomena exist in the human brain. A key challenge in this work is to make
      non-invasive and reproducible measurements of the cerebral microenvironment in humans. For
      these studies, the investigators have implemented a suite of MRI measurements to track
      physiological changes in the brain during sleep. This exploratory work aims to establish the
      sensitivity and reproducibility of MRI as a non-invasive neuroimaging assessment of cerebral
      changes during natural sleep and sedation. The long term goal of this work is to use MRI as
      an imaging biomarker to assess the cerebral response to normal versus disordered sleep in
      patients.

      Our specific aims will address the following questions:

      Aim 1: How sensitive are MRI metrics for determining changes in the brain during sleep?

      Aim 2: How reproducible are MRI metrics during sleep and during sedation?

      The investigators will recruit 12 normal adult subjects for this study (consecutive
      respondees to recruitment adverts). The investigators will make regional MRI measurements
      during onset, maintenance and waking from stage N2 sleep. From these the investigators will
      characterize which MRI metrics are most sensitive to changes in the cerebral environment, and
      how these vary for different cerebral regions.

      Measurements will be repeated during ~90 minutes of natural sleep, and following oral
      sedation with 10 mg zaleplon (Sonata).
observational model: Cohort
time perspective: Prospective
measure: Cerebral MRI Changes
time frame: 90 Minutes of Sleep
description: Change in MRI Signal from Awake Baseline
intervention type: Drug
intervention name: Zaleplon
description: Sleep Aid; 10mg; Oral; Single Use
other name: Sonata
intervention type: Other
intervention name: Natural Sleep
description: Natural Sleep without medication
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: David Dubowitz
investigator title: Associate Professor
mesh term: Zaleplon
sharing ipd: No