Study to Compare Verbal Scores of Children Diagnosed With ASD Who Received Hyperbaric Treatment To Those Who Did Not

A Retrospective Study to Evaluate Verbal Scores of Children Diagnosed With Autism Spectrum Disorder Who Received Hyperbaric Treatment and Those Who Did Not Receive Hyperbaric Treatment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06043284

Enrollment

Registered

2023-09-21

Start date

2018-01-01

Completion date

2022-02-20

Last updated

2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Hyperbaric Oxygen Therapy

Brief summary

A child's ability to effectively communicate with peers, parents, and caregivers impacts their level of independence and quality of personal relationships. This retrospective study will compare the speech development of participants aged 2 - 17 years that received 40 sessions of HBOT at 2.0 ATA to those who had not. Both groups will have a verbal assessment every six months. There were 32 subjects in the HBO group and 33 subjects in the non-HBO group. The statistical analysis will focus on whether Hyperbaric Oxygen Therapy made a significant difference in Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) or Assessment of Basic Language and Learning Skills (ABLLS) results.

Detailed description

Methods: This was a study designed to retrospectively determine any association between hyperbaric oxygen therapy (HBOT) and change in verbal scores in children with autism spectrum disorder (ASD). All children aged 2 to 17 years, diagnosed with ASD who completed a verbal test every six months (either Verbal Behavior Milestones Assessment and Placement Program or the Assessment of Basic Language and Learning Skills), received applied behavioral analysis at Oxford Recovery Center (ORC) were screened for inclusion, some of whom had elected to receive HBOT (at least 40 sessions for 60 minutes at 2.0 ATA).

Interventions

DEVICEHyperbaric Oxygen Therapy

Subjects received 100% medical grade oxygen for 60 minutes at 2.0 ATA for 40 sessions in a hard-sided monoplace hyperbaric chamber

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Diagnosed with autism spectrum disorder by a qualified practitioner * Obtained medical clearance for hyperbaric oxygen therapy * Received applied behavioral analysis at Oxford Recovery Center * Received two of the same age appropriate verbal test 6 months apart

Exclusion criteria

* History of seizure disorder * Diagnosis of genetic or mitochondrial mutation

Design outcomes

Primary

Measure	Time frame	Description
The verbal scores will be measured for children with autism who underwent hyperbaric oxygen therapy and compared to those who did not by an age appropriate assessment.	Change from baseline of verbal scores at 6 months	Verbal testing: Verbal Behavior Milestones Assessment and Placement Program (VBMAPP)
The verbal scores will be measured for children with ASD who underwent hyperbaric oxygen therapy and compared to the those who did not using an age appropriate assessment.	Change from baseline of verbal scores at 6 months	Verbal testing: Assessment of Basic Language and Learning Skills (ABLLS).

Secondary

Measure	Time frame	Description
Number of participants with hyperbaric oxygen treatment related adverse events.	up to 30 weeks	Adverse events were collected during every HBO session only for the treatment group subjects. All verbatim AE terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class (SOC) and, preferred term (PT) and study treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026