NCT04472780

Hyperbaric Oxygen Treatment in Autism Spectrum Disorders

Effect of Hyperbaric Oxygen Therapy (HBOT) in Children With Autism Spectrum Disorder (ASD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: General Administration of Military Health, Tunisia · Network
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Child Autism

Interventions

Type	Name	Description
DEVICE	Hyperbaric oxygen Therapy HBOT	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%

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2020-07-15
• Last updated: 2021-09-22

Locations

1 site across 1 country: Tunisia