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NCT04472780
Hyperbaric Oxygen Treatment in Autism Spectrum Disorders
NA trial testing Hyperbaric oxygen Therapy HBOT in Child Autism in 80 participants. Status unknown.
1 October 2021
Quick facts
| Lead sponsor | General Administration of Military Health, Tunisia |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 June 2019 |
| Primary completion | 1 October 2021 |
| Estimated completion | 1 October 2021 |
| Sites | 1 location across Tunisia |
Drugs / interventions tested
- Hyperbaric oxygen Therapy HBOT
Conditions studied
- Child Autism — all drugs for Child Autism →
Sponsor
General Administration of Military Health, Tunisia — full company profile →
Who can join
Adults 4 to 14, any sex, with Child Autism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04472780
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04472780 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by General Administration of Military Health, Tunisia
- Last refreshed: 22 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04472780.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing