<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/NCT01719315</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0201</org_study_id>
    <nct_id>NCT01719315</nct_id>
  </id_info>
  <brief_title>Neurophysiologic Correlates of Hypersomnia</brief_title>
  <official_title>Neurophysiologic Correlates of Hypersomnia: a High Density EEG Investigation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to examine the neurophysiology of hypersomnia during sleep and&#xD;
      wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders,&#xD;
      and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to&#xD;
      determine if this decreases daytime sleepiness in these patients. The primary study&#xD;
      hypotheses are that individuals with hypersomnolence will have reduced slow wave activity&#xD;
      (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain&#xD;
      regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent&#xD;
      patients will increase SWA during sleep, reduce theta/alpha activity during wake, and improve&#xD;
      subjective sleepiness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Nocturnal Slow Wave Activity</measure>
    <time_frame>Individual nights of sleep recorded within an average of 4 weeks of enrollment</time_frame>
    <description>EEG recordings during sleep will be analyzed to assess slow wave activity in the 1-4.5Hz range.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Waking theta/alpha activity</measure>
    <time_frame>Individual days of waking EEG will be recorded within an average of 4 weeks of enrollment</time_frame>
    <description>Waking EEG activity across the 1-12Hz range will be analyzed.</description>
  </secondary_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Actual">76</enrollment>
  <condition>Major Depressive Disorder</condition>
  <condition>Primary Hypersomnia</condition>
  <condition>Bipolar Disorder</condition>
  <condition>Narcolepsy</condition>
  <condition>Primary Insomnia</condition>
  <arm_group>
    <arm_group_label>MDD with Hypersomnia</arm_group_label>
    <description>Participants with Major Depressive Disorder and co-morbid hypersomnia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MDD without hypersomnia</arm_group_label>
    <description>Participants with Major Depressive Disorder but without co-morbid hypersomnia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BPAD with hypersomnia</arm_group_label>
    <description>Participants with Bipolar Affective Disorder and co-morbid hypersomnia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BPAD without hypersomnia</arm_group_label>
    <description>Participants with Bipolar Affective Disorder without co-morbid hypersomnia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary Hypersomnia</arm_group_label>
    <description>Patients with primary hypersomnia (idiopathic hypersomnia)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary Insomnia</arm_group_label>
    <description>Patients with primary insomnia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Narcolepsy</arm_group_label>
    <description>Subjects with narcolepsy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>healthy participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acoustical slow wave induction</intervention_name>
    <description>Brief tones (50 millisecond duration) at a frequency of 0.8 and 2 Hz, a rate that approximates the natural cellular oscillations of cortical neurons during sleep, will be played in blocks of 15-20 during non-rapid eye movement (NREM) sleep. Blocks of active acoustic slow wave induction will be followed by blocks of equal duration without induction, in order to make comparisons between stimulation periods (ON) and no stimulation periods (OFF). Tone intensity will be manually adjusted so as to be above an individual participant's auditory threshold during waking, but still quiet enough as not to awaken the subject from sleep. Sham slow wave induction will consist of auditory tones played prior to sleep, and during sleep of insufficient timing and intensity to alter slow wave activity.</description>
    <arm_group_label>BPAD with hypersomnia</arm_group_label>
    <arm_group_label>MDD with Hypersomnia</arm_group_label>
    <arm_group_label>Narcolepsy</arm_group_label>
    <arm_group_label>Primary Hypersomnia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from the greater Madison, WI area. Hypersomnolent subject groups&#xD;
        (n=30 in each group) may include unipolar MDD with hypersomnolence, primary hypersomnia&#xD;
        (idiopathic hypersomnia), bipolar disorder with hypersomnolence, and narcolepsy.&#xD;
        Non-hypersomnolent comparison groups (n=30 in each group) will include: MDD without&#xD;
        hypersomnolence, bipolar disorder without hypersomnolence, primary insomnia, and healthy&#xD;
        controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet Diagnostic and Statistical Manual edition IV criteria for neuropsychiatric&#xD;
             disorders enumerated in study population description&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusionary criteria for all subjects will include: evidence of a clinically significant&#xD;
        sleep disorder that would cause hypersomnolence (e.g. moderate to severe obstructive sleep&#xD;
        apnea, restless legs syndrome, shift-work sleep disorder), history of significant head&#xD;
        trauma or loss of consciousness &gt; 30 minutes; current smoking of more than 15 cigarettes&#xD;
        per day; &gt;3 caffeinated beverages per day; significant neurologic or medical illness;&#xD;
        active drug/alcohol abuse/dependence (within 6 months of enrollment), women who are&#xD;
        pregnant, &lt;6 months post-partum, nursing or planning to become pregnant during the study;&#xD;
        left-handedness (due to effects on sleep topography); and imminent risk for self-harm or&#xD;
        suicide.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David T Plante</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin-Madison, Department of Psychiatry</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</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>Narcolepsy</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Disorders of Excessive Somnolence</mesh_term>
    <mesh_term>Idiopathic Hypersomnia</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_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/NCT01719315
org study id: 2012-0201
nct id: NCT01719315
lead sponsor: 
has dmc: No
The goal of this project is to examine the neurophysiology of hypersomnia during sleep and
      wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders,
      and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to
      determine if this decreases daytime sleepiness in these patients. The primary study
      hypotheses are that individuals with hypersomnolence will have reduced slow wave activity
      (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain
      regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent
      patients will increase SWA during sleep, reduce theta/alpha activity during wake, and improve
      subjective sleepiness.
observational model: Case-Control
time perspective: Prospective
measure: Nocturnal Slow Wave Activity
time frame: Individual nights of sleep recorded within an average of 4 weeks of enrollment
description: EEG recordings during sleep will be analyzed to assess slow wave activity in the 1-4.5Hz range.
measure: Waking theta/alpha activity
time frame: Individual days of waking EEG will be recorded within an average of 4 weeks of enrollment
description: Waking EEG activity across the 1-12Hz range will be analyzed.
arm group label: MDD with Hypersomnia
description: Participants with Major Depressive Disorder and co-morbid hypersomnia
arm group label: MDD without hypersomnia
description: Participants with Major Depressive Disorder but without co-morbid hypersomnia
arm group label: BPAD with hypersomnia
description: Participants with Bipolar Affective Disorder and co-morbid hypersomnia
arm group label: BPAD without hypersomnia
description: Participants with Bipolar Affective Disorder without co-morbid hypersomnia
arm group label: Primary Hypersomnia
description: Patients with primary hypersomnia (idiopathic hypersomnia)
arm group label: Primary Insomnia
description: Patients with primary insomnia
arm group label: Narcolepsy
description: Subjects with narcolepsy
arm group label: Healthy Controls
description: healthy participants
intervention type: Other
intervention name: Acoustical slow wave induction
description: Brief tones (50 millisecond duration) at a frequency of 0.8 and 2 Hz, a rate that approximates the natural cellular oscillations of cortical neurons during sleep, will be played in blocks of 15-20 during non-rapid eye movement (NREM) sleep. Blocks of active acoustic slow wave induction will be followed by blocks of equal duration without induction, in order to make comparisons between stimulation periods (ON) and no stimulation periods (OFF). Tone intensity will be manually adjusted so as to be above an individual participant's auditory threshold during waking, but still quiet enough as not to awaken the subject from sleep. Sham slow wave induction will consist of auditory tones played prior to sleep, and during sleep of insufficient timing and intensity to alter slow wave activity.
arm group label: BPAD with hypersomnia
arm group label: MDD with Hypersomnia
arm group label: Narcolepsy
arm group label: Primary Hypersomnia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David T Plante
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Narcolepsy
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Disorders of Excessive Somnolence
mesh term: Idiopathic Hypersomnia
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Bipolar Disorder