<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/NCT03768713</url>
  </required_header>
  <id_info>
    <org_study_id>JC101320-FC</org_study_id>
    <nct_id>NCT03768713</nct_id>
  </id_info>
  <brief_title>Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Suvorexant (Belsomra®) on Sympathetic Neural Activity and Baroreflex Function in Patients With Chronic Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montana State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Montana State University</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aims to evaluate the effect of Suvorexant on sympathetic nerve activity and&#xD;
      baroreflex function in subject with chronic insomnia. The investigator's central hypothesis&#xD;
      is that Suvorexant will reduce sympathetic nerve activity and improve baroreflex function&#xD;
      when compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will utilize a randomized, double-blind, placebo-controlled experimental approach&#xD;
      to determine the effects of 8-wk treatment with Suvorexant (Belsomra®) on sympathetic nerve&#xD;
      activity and baroreflex function in male and female subjects with chronic insomnia. The study&#xD;
      will utilize established techniques for assessing sleep (polysomnography), blood pressure&#xD;
      (sphygmomanometer and beat-to-beat finger plethysmography), and peripheral sympathetic nerve&#xD;
      activity (microneurography). The study will stratify enrollment based upon both age and sex&#xD;
      (i.e., male vs. female) because these two covariates are known to influence sympathetic nerve&#xD;
      activity and baroreflex function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 18, 2019</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Phase 4</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sympathetic nerve activity</measure>
    <time_frame>8 weeks</time_frame>
    <description>Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baroreflex sensitivity</measure>
    <time_frame>8 weeks</time_frame>
    <description>The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sympathetic reactivity</measure>
    <time_frame>8 weeks</time_frame>
    <description>The change in muscle sympathetic nerve activity during a cold pressor test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Home sleep quality: Wrist actigraphy</measure>
    <time_frame>8 weeks</time_frame>
    <description>Wrist actigraphy will be used to to determine the quality of sleep, with a primary focus on sleep efficiency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory sleep quality: Polysomnography</measure>
    <time_frame>8 week</time_frame>
    <description>Polysomnography will be used to determine the quality of sleep, with a primary focus on sleep efficiency.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Chronic Insomnia</condition>
  <arm_group>
    <arm_group_label>Drug (Suvorexant)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mg of Suvorexant daily (taken orally ~1 hour before bedtime)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20 mg of Placebo daily (taken orally ~1 hour before bedtime)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Suvorexant</intervention_name>
    <description>Insomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks.</description>
    <arm_group_label>Drug (Suvorexant)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Insomnia subjects will take a nightly pill of 20 mg placebo for eight weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum 3 months of clinically diagnosed insomnia&#xD;
&#xD;
          -  Body mass index ≤35 kg/m2&#xD;
&#xD;
          -  Insomnia Severity Index (ISI) &gt; 7 arbitrary units (i.e., mild-to-severe insomnia)&#xD;
&#xD;
          -  Pre-menopausal women must have regular menstrual cycles (~26-30 day cycles) and will&#xD;
             be scheduled for microneurography 2-7 days after menstruation to consistently test&#xD;
             during the early follicular phase (or low-hormone phase in women on contraceptives)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or prior treatment of Suvorexant.&#xD;
&#xD;
          -  Obstructive sleep apnea defined as an apnea-hypopnea index &gt; 30 using an FDA approved&#xD;
             home sleep apnea screening devices as used in routine clinical practice.&#xD;
&#xD;
          -  Participants without evidence of clinically significant obstructive sleep apnea on the&#xD;
             screening test will undergo an overnight in-laboratory polysomnography to confirm&#xD;
             absence of sleep apnea (apnea-hypopnea index of ≥ 30 episodes per hour) and to exclude&#xD;
             other sleep disorders (e.g. periodic limb movement arousal index of ≥ 5 episodes per&#xD;
             hour)&#xD;
&#xD;
          -  Circadian rhythm sleep disorders&#xD;
&#xD;
          -  History of meeting DSM-V criteria of major psychiatric disorder&#xD;
&#xD;
          -  Have been clinically-diagnosed with diabetes, cardiovascular disease, or any other&#xD;
             unstable or serious medical condition.&#xD;
&#xD;
          -  Current, or use within past month, of psychoactive (other than stable treatment with&#xD;
             antidepressant or antianxiety), hypnotic, stimulant or analgesic medication (except&#xD;
             occasional non-narcotic analgesics)&#xD;
&#xD;
          -  Shift work or other types of self-imposed irregular sleep schedules&#xD;
&#xD;
          -  Habitual smoking (6 or more cigarettes per week)&#xD;
&#xD;
          -  Habitual alcohol consumption (more than 2 alcoholic drinks per day)&#xD;
&#xD;
          -  Breastfeeding or pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Carter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montana State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne Tikkanen</last_name>
    <phone>406-994-2292</phone>
    <email>anne.tikkanen@montana.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jeremy Bigalke</last_name>
    <phone>406-994-2292</phone>
    <email>jeremy.bigalke@student.montana.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Montana State University</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59717</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Tikkanen</last_name>
      <phone>406-994-2292</phone>
      <email>anne.tikkanen@montana.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2021</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 Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suvorexant</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/NCT03768713
org study id: JC101320-FC
nct id: NCT03768713
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study aims to evaluate the effect of Suvorexant on sympathetic nerve activity and
      baroreflex function in subject with chronic insomnia. The investigator's central hypothesis
      is that Suvorexant will reduce sympathetic nerve activity and improve baroreflex function
      when compared to placebo.
This study will utilize a randomized, double-blind, placebo-controlled experimental approach
      to determine the effects of 8-wk treatment with Suvorexant (Belsomra®) on sympathetic nerve
      activity and baroreflex function in male and female subjects with chronic insomnia. The study
      will utilize established techniques for assessing sleep (polysomnography), blood pressure
      (sphygmomanometer and beat-to-beat finger plethysmography), and peripheral sympathetic nerve
      activity (microneurography). The study will stratify enrollment based upon both age and sex
      (i.e., male vs. female) because these two covariates are known to influence sympathetic nerve
      activity and baroreflex function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Sympathetic nerve activity
time frame: 8 weeks
description: Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.
measure: Baroreflex sensitivity
time frame: 8 weeks
description: The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity.
measure: Sympathetic reactivity
time frame: 8 weeks
description: The change in muscle sympathetic nerve activity during a cold pressor test.
measure: Home sleep quality: Wrist actigraphy
time frame: 8 weeks
description: Wrist actigraphy will be used to to determine the quality of sleep, with a primary focus on sleep efficiency.
measure: Laboratory sleep quality: Polysomnography
time frame: 8 week
description: Polysomnography will be used to determine the quality of sleep, with a primary focus on sleep efficiency.
arm group label: Drug (Suvorexant)
arm group type: Experimental
description: 20 mg of Suvorexant daily (taken orally ~1 hour before bedtime)
arm group label: Placebo
arm group type: Placebo Comparator
description: 20 mg of Placebo daily (taken orally ~1 hour before bedtime)
intervention type: Drug
intervention name: Suvorexant
description: Insomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks.
arm group label: Drug (Suvorexant)
intervention type: Drug
intervention name: Placebo
description: Insomnia subjects will take a nightly pill of 20 mg placebo for eight weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jason Carter, PhD
role: Principal Investigator
affiliation: Montana State University
last name: Anne Tikkanen
phone: 406-994-2292
email: anne.tikkanen@montana.edu
last name: Jeremy Bigalke
phone: 406-994-2292
email: jeremy.bigalke@student.montana.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Suvorexant
sharing ipd: No