<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/NCT02217371</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2013/06</org_study_id>
    <nct_id>NCT02217371</nct_id>
  </id_info>
  <brief_title>Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity</brief_title>
  <acronym>VEILLETDAH</acronym>
  <official_title>Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a previous protocol, we highlighted an excessive daytime sleepiness at the Maintenance of&#xD;
      Wakefulness Tests (MWT) in 36% of adult Attention Deficit Disorder with or without&#xD;
      Hyperactivity (ADHD) patients. In 40% of cases this sleepiness was associated with a sleep&#xD;
      disorder objectified by polysomnography (PSG): apnea hypopnea syndrome (AHI) ≥ 10/h and / or&#xD;
      Periodicals Movements of Lower Limb (PLMI) ≥ 15/h. However, among patients with no sleep&#xD;
      disorder PSG, we can question the central origin of the Excessive Daytime Sleepiness. Thus,&#xD;
      we wish to determine potential changes in the regulation of sleep / wake cycle through a&#xD;
      protocol of extended wake.&#xD;
&#xD;
      The principal objective is to compare the objective sleepiness in sleepy patients with ADHD&#xD;
      and healthy subjects during a protocol of extended wake.&#xD;
&#xD;
      It's an observational study of interventional type realized in patient with ADHD syndrome&#xD;
      deprived of psychostimulant treatment (for 72 hours) and healthy subject, investigating the&#xD;
      implication of the homeostatic and circadian systems in the preservation of awakening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2014</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of objective sleepiness</measure>
    <time_frame>at inclusion (day 0)</time_frame>
    <description>Comparison of objective sleepiness in sleepy patients with ADHD and healthy subjects during a protocol of extended wake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Theta-alpha band of EEG sleep</measure>
    <time_frame>At inclusion (Day 0)</time_frame>
    <description>Time constant and asymptotic value of the spectral power of the theta-alpha band of EEG sleep</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amplitude and phase of internal temperature</measure>
    <time_frame>At inclusion (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Karolinska Sleepiness Scale (subjective measure of sleepiness)</measure>
    <time_frame>At inclusion (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Results of the neuropsychological tests</measure>
    <time_frame>At inclusion (day 0)</time_frame>
    <description>Go/NoGO paradigm&#xD;
Continuous Performance Test and virtual Continuous Performance Test&#xD;
Stroop test and virtual stroop test&#xD;
Wisconsin Card Sorting Test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Attention-Deficit/Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>ADHD patient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neuropsychological tests</intervention_name>
    <description>The tests are :&#xD;
Go/NoGo paradigm, Continuous Performance Test (CPT) II , Wisconsin Card Sorting Test (WCST), virtual CPT, Classic and virtual Stroop, PSG, MWT&#xD;
These tests will be repeated during 32h each 4h (T0h, T4h, T8h, T12h, T16h, T20h, T24h, T28h et T32h).</description>
    <arm_group_label>ADHD patient</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For ADHD patient:&#xD;
&#xD;
          -  Patients male or feminine, from 18 to 50 years old,&#xD;
&#xD;
          -  Patient respondent in the criterion current diagnosis of the ADHD according to the&#xD;
             Diagnostic and Statistical Manual of Mental Disorders (DSM) IV-TR,&#xD;
&#xD;
          -  Meeting the criteria diagnosis of ADHD in the childhood, estimated by the interview &quot;&#xD;
             Conners'Adult ADHD Diagnostic Interview for DSM-IV &quot; (CAADID),&#xD;
&#xD;
          -  Patient presenting a total score ≥ 20 at CAARS With at least 6 items of money scales&#xD;
             inattention or hyperactivity ≥ 2,&#xD;
&#xD;
          -  Patients deprived of any psychostimulants for 72 hours,&#xD;
&#xD;
          -  Presenting at the polygraphy the absence of night-respiratory disorders (AHI &lt; 10 /&#xD;
             hour) and of Periodic Limbs Movements (PLMI &lt; 15 / hour), as well as the absence of&#xD;
             restless legs syndrome at the interview,&#xD;
&#xD;
          -  Presenting to the MWT an excessive daytime sleepiness: mean latency &lt; 20 min,&#xD;
&#xD;
          -  Absence of syndrome of phase delay according to the criteria of l'ICSD2 (International&#xD;
             Classification Sleep Disorders),&#xD;
&#xD;
          -  Having been schooled until class of 3rd,&#xD;
&#xD;
          -  Having regular schedules of life 4 days before going into the study,&#xD;
&#xD;
          -  Beneficiary of a national insurance scheme,&#xD;
&#xD;
          -  Having given in writing their informed consent to participate in the study.&#xD;
&#xD;
        For healthy subject:&#xD;
&#xD;
          -  Patients male or feminine, from 18 to 50 years old,&#xD;
&#xD;
          -  Subjects not symptomatic of ADHD (Total score at the Wender Utah Rating Scale strictly&#xD;
             lower than 46 on 25 questions concerning the ADHD, and less than four crosses in the&#xD;
             more darker cases of first 6 questions of ASRS),&#xD;
&#xD;
          -  Subjects not presenting complaints of sleep, nor excessive daytime sleepiness (No item&#xD;
             equal to 4 or 5 at Basic Nordic Sleep Questionnaire (BNSQ), excepted items 16 and 17&#xD;
             and total score at the Epworth Sleepiness Scale &lt; 11),&#xD;
&#xD;
          -  Presenting at the polygraphy the absence of night-respiratory disorders (AHI &lt; 10 /&#xD;
             hour) and of Periodic Limbs Movements (PLMI &lt; 15 / hour), as well as the absence of&#xD;
             restless legs syndromeat the interview,&#xD;
&#xD;
          -  Not presenting to the MWT an excessive daytime sleepiness: mean latency &gt; 34 min,&#xD;
&#xD;
          -  Absence of syndrome of phase delay according to the criteria of l'ICSD2 (International&#xD;
             Classification Sleep Disorders),&#xD;
&#xD;
          -  Having been schooled until class of 3rd,&#xD;
&#xD;
          -  Having regular schedules of life 4 days before going into the study,&#xD;
&#xD;
          -  Beneficiary of a national insurance scheme,&#xD;
&#xD;
          -  Having given in writing their informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Posted or night work,&#xD;
&#xD;
          -  Any evolutionary affection (Brain tumour, epilepsy, migraine, cerebral vascular&#xD;
             accident, calcifies, myoclonia, chorea, neuropathy, muscular dystrophies, dystrophy&#xD;
             myotonic…),&#xD;
&#xD;
          -  Psychiatric comorbidity: Current major depressive episode, current hypo obsessive or&#xD;
             obsessive episode, schizophrenia,&#xD;
&#xD;
          -  Renal disorders (Renal insufficiency, nephrolithiasis...),&#xD;
&#xD;
          -  Endocrine pathologies (dysthyroidism, diabetes),&#xD;
&#xD;
          -  Drug addiction during the last 6 months,&#xD;
&#xD;
          -  Alcohol addiction during the last 6 months,&#xD;
&#xD;
          -  Dependence in the tetra-hydroxy-cannabinol during the last 6 months,&#xD;
&#xD;
          -  Long-term treatment by benzodiazepines,&#xD;
&#xD;
          -  Treatment by atomoxetine,&#xD;
&#xD;
          -  Pregnant and breast-feeding women,&#xD;
&#xD;
          -  People under supervision, guardianship,&#xD;
&#xD;
          -  Person incapable to give personally its consent,&#xD;
&#xD;
          -  Nobody in emergency situation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cyril CHAUFTON, Md</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antoine BENARD, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>May 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD Patient</keyword>
  <keyword>Healthy subjects</keyword>
  <keyword>Sleepiness</keyword>
  <keyword>PSG</keyword>
  <keyword>MWT</keyword>
  <keyword>EEG</keyword>
  <keyword>cognitive tests</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</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/NCT02217371
org study id: CHUBX 2013/06
nct id: NCT02217371
lead sponsor: 
has dmc: No
In a previous protocol, we highlighted an excessive daytime sleepiness at the Maintenance of
      Wakefulness Tests (MWT) in 36% of adult Attention Deficit Disorder with or without
      Hyperactivity (ADHD) patients. In 40% of cases this sleepiness was associated with a sleep
      disorder objectified by polysomnography (PSG): apnea hypopnea syndrome (AHI) ≥ 10/h and / or
      Periodicals Movements of Lower Limb (PLMI) ≥ 15/h. However, among patients with no sleep
      disorder PSG, we can question the central origin of the Excessive Daytime Sleepiness. Thus,
      we wish to determine potential changes in the regulation of sleep / wake cycle through a
      protocol of extended wake.

      The principal objective is to compare the objective sleepiness in sleepy patients with ADHD
      and healthy subjects during a protocol of extended wake.

      It's an observational study of interventional type realized in patient with ADHD syndrome
      deprived of psychostimulant treatment (for 72 hours) and healthy subject, investigating the
      implication of the homeostatic and circadian systems in the preservation of awakening.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Comparison of objective sleepiness
time frame: at inclusion (day 0)
description: Comparison of objective sleepiness in sleepy patients with ADHD and healthy subjects during a protocol of extended wake.
measure: Theta-alpha band of EEG sleep
time frame: At inclusion (Day 0)
description: Time constant and asymptotic value of the spectral power of the theta-alpha band of EEG sleep
measure: Amplitude and phase of internal temperature
time frame: At inclusion (day 0)
measure: Score of Karolinska Sleepiness Scale (subjective measure of sleepiness)
time frame: At inclusion (day 0)
measure: Results of the neuropsychological tests
time frame: At inclusion (day 0)
description: Go/NoGO paradigm
Continuous Performance Test and virtual Continuous Performance Test
Stroop test and virtual stroop test
Wisconsin Card Sorting Test
arm group label: ADHD patient
arm group type: Experimental
arm group label: Healthy volunteers
arm group type: Active Comparator
intervention type: Other
intervention name: Neuropsychological tests
description: The tests are :
Go/NoGo paradigm, Continuous Performance Test (CPT) II , Wisconsin Card Sorting Test (WCST), virtual CPT, Classic and virtual Stroop, PSG, MWT
These tests will be repeated during 32h each 4h (T0h, T4h, T8h, T12h, T16h, T20h, T24h, T28h et T32h).
arm group label: ADHD patient
arm group label: Healthy volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cyril CHAUFTON, Md
role: Principal Investigator
affiliation: University Hospital, Bordeaux
last name: Antoine BENARD, MD
role: Study Chair
affiliation: University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity