Hyperbaric Oxygen Treatment in Autism Spectrum Disorders

NCT04472780 | Unknown

• 1 other identifier: Autism spectrum disorder
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Autism

Keywords

ASD - HBOT -

Outcome Measures

Primary Outcomes (1)

• clinical severity assesement

  Evaluate the interest of hyperbaric oxygen therapy in the management of ASD using CARS (child autism rating scale)

  03 months

Secondary Outcomes (4)

• dosage of Inetreleukine 6

  03 months

• dosage of TNFα

  03 months

• Oxidatif stress profil

  03 months

• dosage of Glutathione peroxidase

  03 months

Study Arms (2)

HBOT Group

EXPERIMENTAL

will benefit from HBOT

Device: Hyperbaric oxygen Therapy HBOT

Control group

NO INTERVENTION

will benefit from the conventional treatment

Interventions

Hyperbaric oxygen Therapy HBOT DEVICE

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%

HBOT Group

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• Children with hearing or visual impairments
• Children with unbalanced epilepsy
• Children with a contraindication to HBOT
• Dysfunction of the immune system

You may not qualify if:

• Child that havent completed entire protocol

Sponsors & Collaborators

• General Administration of Military Health, Tunisia: lead
• Military Hospital of Tunis: collaborator

Study Sites (1)

HBOT Department Military Hospital

Tunis, Montfleury, 1008, Tunisia

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Hedi Gharsallah, Doctor

CONTACT

71391885; gharsallahhedi@gmail.com

Hela Slama, Doctor

CONTACT

29407348; slamahela2003@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: July 15, 2020
• Study Start: June 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)