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Completed

NCT Number: NCT06043284

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

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.

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Key information

Conditions

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

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oxford Recovery Center, Brighton, Michigan, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyperbaric oxygen therapy

Device

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

Primary outcomes

  1. 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.

    Time frame: Change from baseline of verbal scores at 6 months

    Verbal testing: Verbal Behavior Milestones Assessment and Placement Program (VBMAPP)

  2. 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.

    Time frame: Change from baseline of verbal scores at 6 months

    Verbal testing: Assessment of Basic Language and Learning Skills (ABLLS).

Secondary outcomes

  1. Number of participants with hyperbaric oxygen treatment related adverse events.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oxford Recovery Center

Other

Collaborators

  • The Oxford Center

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 21, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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