<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/NCT04472780</url>
  </required_header>
  <id_info>
    <org_study_id>Autism spectrum disorder</org_study_id>
    <nct_id>NCT04472780</nct_id>
  </id_info>
  <brief_title>Hyperbaric Oxygen Treatment in Autism Spectrum Disorders</brief_title>
  <official_title>Effect of Hyperbaric Oxygen Therapy (HBOT) in Children With Autism Spectrum Disorder (ASD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>General Administration of Military Health, Tunisia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Military Hospital of Tunis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>General Administration of Military Health, Tunisia</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>
      Hyperbaric oxygen therapy (HBOT) is part of a multidisciplinary therapeutic management of&#xD;
      infant autism including psychotherapy, drug treatment and other therapeutics (speech therapy,&#xD;
      occupational therapy restrictive diet ...).&#xD;
&#xD;
      It has been postulated that children with autism may benefit from HBOT due to the potential&#xD;
      increase in cerebral perfusion occurring during treatment.&#xD;
&#xD;
      In fact, inhaling oxygen above atmospheric pressure could cause an increase in the arterial&#xD;
      partial pressure of oxygen, leading to increased oxygen supply to the brain. HBO may also&#xD;
      have anti-inflammatory properties due to the reduction in pro-inflammatory cytokines (tumor&#xD;
      necrosis factor -α, interferon-γ and interleukins1 and 6). In addition, HBOT could improve&#xD;
      mitochondrial dysfunction effects, as well as upregulate the production of antioxidant&#xD;
      enzymes.Thus, hyperbaric oxygen therapy could be tried among the therapeutic arsenal of&#xD;
      adjuvant treatments for autism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties&#xD;
      in verbal and non-verbal communication and social interactions. People with ASD often exhibit&#xD;
      difficult behaviors, including aggressiveness, temper tantrums, irritability, hyperactivity,&#xD;
      inattention, impulsivity, self-harm ..&#xD;
&#xD;
      The increasing prevalence of autism spectrum disorders (approximately 1%) has increased the&#xD;
      need for evidence-based treatment to lessen the impact of symptoms.&#xD;
&#xD;
      The ethiopathogenesis of ASD has so far been unclear. Current pathophysiological theories&#xD;
      have demonstrated the presence of cerebral hypo-perfusion, neuro-inflammation, immune&#xD;
      dysregulation and oxidative stress involved in the genesis of this disorder. Based on its&#xD;
      anti-inflammatory effects and increased amount of dissolved oxygen, hyperbaric oxygen therapy&#xD;
      has been tried as one of the therapeutic arsenals of adjuvant therapy for autism.&#xD;
&#xD;
      This is a randomized controlled study including nearly 80 patients with ASD who underwent&#xD;
      clinical and neuropsychological evaluation before and after HBOT treatment as well as the&#xD;
      dosage of the various biochemical and immunological markers. These markers will be assessed&#xD;
      before and after the HBOT. Perfusion MRI would also be performed before and after HBO.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2021</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Randomized controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical severity assesement</measure>
    <time_frame>03 months</time_frame>
    <description>Evaluate the interest of hyperbaric oxygen therapy in the management of ASD using CARS (child autism rating scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>dosage of Inetreleukine 6</measure>
    <time_frame>03 months</time_frame>
    <description>Evaluate the effect of HBOT on pro-inflammatory cytokines by Immunoassays: IL6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dosage of TNFα</measure>
    <time_frame>03 months</time_frame>
    <description>Evaluate the effect of HBOT on pro-inflammatory cytokines by Immunoassays: TNFα</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidatif stress profil</measure>
    <time_frame>03 months</time_frame>
    <description>Evaluate the effect of HBOT on the level of oxidative stress BY Biochemical dosages: Total antioxidant status (SAT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dosage of Glutathione peroxidase</measure>
    <time_frame>03 months</time_frame>
    <description>Evaluate the effect of HBOT on the level of oxidative stress BY Biochemical dosages: Glutathione peroxidase</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Child Autism</condition>
  <arm_group>
    <arm_group_label>HBOT Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will benefit from HBOT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>will benefit from the conventional treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hyperbaric oxygen Therapy HBOT</intervention_name>
    <description>HBOT therapy protocol: in an eight-seat hyperbaric chamber 40 sessions of HBOT duration: 1 hour rhythm: 5 sessions / week pressure: 1.7 ATA (7 meters) O2 concentration: 100%</description>
    <arm_group_label>HBOT Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children aged 4 to 14 years who were followed in the child psychiatry unit during&#xD;
             the study period and who were identified as having a diagnosis of ASD. This diagnosis&#xD;
             was made by child psychiatrists experienced in autism using the DSM-5 criteria and the&#xD;
             ADI and the Childhood Autism Rating Scale (CARS)&#xD;
&#xD;
        Criteria for non-inclusion :&#xD;
&#xD;
          -  Children with hearing or visual impairments&#xD;
&#xD;
          -  Children with unbalanced epilepsy&#xD;
&#xD;
          -  Children with a contraindication to HBOT&#xD;
&#xD;
          -  Dysfunction of the immune system&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        -Child that havent completed entire protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hedi Gharsallah, Doctor</last_name>
    <phone>71391885</phone>
    <phone_ext>00216</phone_ext>
    <email>gharsallahhedi@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hela Slama, Doctor</last_name>
    <phone>29407348</phone>
    <phone_ext>00216</phone_ext>
    <email>slamahela2003@yahoo.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>HBOT Department Military Hospital</name>
      <address>
        <city>Tunis</city>
        <state>Montfleury</state>
        <zip>1008</zip>
        <country>Tunisia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hedi Gharsallah, MD</last_name>
      <phone>71390885</phone>
      <phone_ext>00216</phone_ext>
      <email>gharsallahhedi@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Hela Slama, MD</last_name>
    </contact_backup>
    <investigator>
      <last_name>Emna Cherif, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mouna Azeiz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Manel Ayoub, PH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Imen Mzoughi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lamjed Msoli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASD - HBOT -</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_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/NCT04472780
org study id: Autism spectrum disorder
nct id: NCT04472780
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hyperbaric oxygen therapy (HBOT) is part of a multidisciplinary therapeutic management of
      infant autism including psychotherapy, drug treatment and other therapeutics (speech therapy,
      occupational therapy restrictive diet ...).

      It has been postulated that children with autism may benefit from HBOT due to the potential
      increase in cerebral perfusion occurring during treatment.

      In fact, inhaling oxygen above atmospheric pressure could cause an increase in the arterial
      partial pressure of oxygen, leading to increased oxygen supply to the brain. HBO may also
      have anti-inflammatory properties due to the reduction in pro-inflammatory cytokines (tumor
      necrosis factor -α, interferon-γ and interleukins1 and 6). In addition, HBOT could improve
      mitochondrial dysfunction effects, as well as upregulate the production of antioxidant
      enzymes.Thus, hyperbaric oxygen therapy could be tried among the therapeutic arsenal of
      adjuvant treatments for autism.
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties
      in verbal and non-verbal communication and social interactions. People with ASD often exhibit
      difficult behaviors, including aggressiveness, temper tantrums, irritability, hyperactivity,
      inattention, impulsivity, self-harm ..

      The increasing prevalence of autism spectrum disorders (approximately 1%) has increased the
      need for evidence-based treatment to lessen the impact of symptoms.

      The ethiopathogenesis of ASD has so far been unclear. Current pathophysiological theories
      have demonstrated the presence of cerebral hypo-perfusion, neuro-inflammation, immune
      dysregulation and oxidative stress involved in the genesis of this disorder. Based on its
      anti-inflammatory effects and increased amount of dissolved oxygen, hyperbaric oxygen therapy
      has been tried as one of the therapeutic arsenals of adjuvant therapy for autism.

      This is a randomized controlled study including nearly 80 patients with ASD who underwent
      clinical and neuropsychological evaluation before and after HBOT treatment as well as the
      dosage of the various biochemical and immunological markers. These markers will be assessed
      before and after the HBOT. Perfusion MRI would also be performed before and after HBO.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: clinical severity assesement
time frame: 03 months
description: Evaluate the interest of hyperbaric oxygen therapy in the management of ASD using CARS (child autism rating scale)
measure: dosage of Inetreleukine 6
time frame: 03 months
description: Evaluate the effect of HBOT on pro-inflammatory cytokines by Immunoassays: IL6
measure: dosage of TNFα
time frame: 03 months
description: Evaluate the effect of HBOT on pro-inflammatory cytokines by Immunoassays: TNFα
measure: Oxidatif stress profil
time frame: 03 months
description: Evaluate the effect of HBOT on the level of oxidative stress BY Biochemical dosages: Total antioxidant status (SAT)
measure: dosage of Glutathione peroxidase
time frame: 03 months
description: Evaluate the effect of HBOT on the level of oxidative stress BY Biochemical dosages: Glutathione peroxidase
arm group label: HBOT Group
arm group type: Experimental
description: will benefit from HBOT
arm group label: Control group
arm group type: No Intervention
description: will benefit from the conventional treatment
intervention type: Device
intervention name: Hyperbaric oxygen Therapy HBOT
description: HBOT therapy protocol: in an eight-seat hyperbaric chamber 40 sessions of HBOT duration: 1 hour rhythm: 5 sessions / week pressure: 1.7 ATA (7 meters) O2 concentration: 100%
arm group label: HBOT Group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 14 Years
healthy volunteers: No
last name: Hedi Gharsallah, Doctor
phone: 71391885
phone ext: 00216
email: gharsallahhedi@gmail.com
last name: Hela Slama, Doctor
phone: 29407348
phone ext: 00216
email: slamahela2003@yahoo.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Tunisia
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No