Phase 3
Completed N=10
Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism
Source: ClinicalTrials.gov NCT00584480 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Apr 2012
Primary outcomePrimary: Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score — 5; 5; 10 participants
Summary
The purpose of this study is to increase the understanding of the effect of Hyperbaric Oxygen Treatment (HBOT) on the behavior and functioning of children with autism. The main goal of this study is to demonstrate that HBOT is safe and tolerable in autistic children, and to measure the effect of HBOT on specific chemicals in their blood that may play a role in the child's behavior.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score |
5; 5; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of DSM-IV defined autism and meets cut off for autism on the Autism Diagnostic Inventory-Revised (ADI-R) or Social Communication Questionnaire (SCQ) and the Autism Diagnostic Observation Scale (ADOS).
- Age 3 to 8 years.
- Nonverbal IQ of 50 or above.
- Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 20 week intervention.
Exclusion Criteria
- Clinical evidence of seizure disorder
- Active infection with fever
- Fragile X or other known genetic cause of autism
- Perinatal brain injury (e.g. cerebral palsy)
- Previous adequate trial (at least 20 session) of HBOT
- Inability to clear ears in the HBOT chambers
Data sourced from ClinicalTrials.gov (NCT00584480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.