Hyperbaric Oxygen Treatment in Autism Spectrum Disorders
Primary Purpose
Child Autism
Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Hyperbaric oxygen Therapy HBOT
Sponsored by
About this trial
This is an interventional treatment trial for Child Autism focused on measuring ASD - HBOT -
Eligibility Criteria
Inclusion Criteria:
- All children aged 4 to 14 years who were followed in the child psychiatry unit during the study period and who were identified as having a diagnosis of ASD. This diagnosis was made by child psychiatrists experienced in autism using the DSM-5 criteria and the ADI and the Childhood Autism Rating Scale (CARS)
Criteria for non-inclusion :
- Children with hearing or visual impairments
- Children with unbalanced epilepsy
- Children with a contraindication to HBOT
- Dysfunction of the immune system
Exclusion criteria
-Child that havent completed entire protocol
Sites / Locations
- HBOT Department Military HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HBOT Group
Control group
Arm Description
will benefit from HBOT
will benefit from the conventional treatment
Outcomes
Primary Outcome Measures
clinical severity assesement
Evaluate the interest of hyperbaric oxygen therapy in the management of ASD using CARS (child autism rating scale)
Secondary Outcome Measures
dosage of Inetreleukine 6
Evaluate the effect of HBOT on pro-inflammatory cytokines by Immunoassays: IL6
dosage of TNFα
Evaluate the effect of HBOT on pro-inflammatory cytokines by Immunoassays: TNFα
Oxidatif stress profil
Evaluate the effect of HBOT on the level of oxidative stress BY Biochemical dosages: Total antioxidant status (SAT)
dosage of Glutathione peroxidase
Evaluate the effect of HBOT on the level of oxidative stress BY Biochemical dosages: Glutathione peroxidase
Full Information
NCT ID
NCT04472780
First Posted
June 3, 2020
Last Updated
September 21, 2021
Sponsor
General Administration of Military Health, Tunisia
Collaborators
Military Hospital of Tunis
1. Study Identification
Unique Protocol Identification Number
NCT04472780
Brief Title
Hyperbaric Oxygen Treatment in Autism Spectrum Disorders
Official Title
Effect of Hyperbaric Oxygen Therapy (HBOT) in Children With Autism Spectrum Disorder (ASD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Administration of Military Health, Tunisia
Collaborators
Military Hospital of Tunis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Autism
Keywords
ASD - HBOT -
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HBOT Group
Arm Type
Experimental
Arm Description
will benefit from HBOT
Arm Title
Control group
Arm Type
No Intervention
Arm Description
will benefit from the conventional treatment
Intervention Type
Device
Intervention Name(s)
Hyperbaric oxygen Therapy HBOT
Intervention 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%
Primary Outcome Measure Information:
Title
clinical severity assesement
Description
Evaluate the interest of hyperbaric oxygen therapy in the management of ASD using CARS (child autism rating scale)
Time Frame
03 months
Secondary Outcome Measure Information:
Title
dosage of Inetreleukine 6
Description
Evaluate the effect of HBOT on pro-inflammatory cytokines by Immunoassays: IL6
Time Frame
03 months
Title
dosage of TNFα
Description
Evaluate the effect of HBOT on pro-inflammatory cytokines by Immunoassays: TNFα
Time Frame
03 months
Title
Oxidatif stress profil
Description
Evaluate the effect of HBOT on the level of oxidative stress BY Biochemical dosages: Total antioxidant status (SAT)
Time Frame
03 months
Title
dosage of Glutathione peroxidase
Description
Evaluate the effect of HBOT on the level of oxidative stress BY Biochemical dosages: Glutathione peroxidase
Time Frame
03 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All children aged 4 to 14 years who were followed in the child psychiatry unit during the study period and who were identified as having a diagnosis of ASD. This diagnosis was made by child psychiatrists experienced in autism using the DSM-5 criteria and the ADI and the Childhood Autism Rating Scale (CARS)
Criteria for non-inclusion :
Children with hearing or visual impairments
Children with unbalanced epilepsy
Children with a contraindication to HBOT
Dysfunction of the immune system
Exclusion criteria
-Child that havent completed entire protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hedi Gharsallah, Doctor
Phone
71391885
Ext
00216
Email
gharsallahhedi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hela Slama, Doctor
Phone
29407348
Ext
00216
Email
slamahela2003@yahoo.fr
Facility Information:
Facility Name
HBOT Department Military Hospital
City
Tunis
State/Province
Montfleury
ZIP/Postal Code
1008
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hedi Gharsallah, MD
Phone
71390885
Ext
00216
Email
gharsallahhedi@gmail.com
First Name & Middle Initial & Last Name & Degree
Hela Slama, MD
First Name & Middle Initial & Last Name & Degree
Emna Cherif, MD
First Name & Middle Initial & Last Name & Degree
Mouna Azeiz, MD
First Name & Middle Initial & Last Name & Degree
Manel Ayoub, PH
First Name & Middle Initial & Last Name & Degree
Imen Mzoughi, MD
First Name & Middle Initial & Last Name & Degree
Lamjed Msoli, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Hyperbaric Oxygen Treatment in Autism Spectrum Disorders
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