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Clinical Trials/NCT06043284
NCT06043284
Completed
N/A

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

Oxford Recovery Center1 site in 1 country65 target enrollmentJanuary 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Oxford Recovery Center
Enrollment
65
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
February 20, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oxford Recovery Center
Responsible Party
Principal Investigator
Principal Investigator

Tami Peterson PhD

Principal Investigator

Oxford Recovery Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

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

  • Number of participants with hyperbaric oxygen treatment related adverse events.(up to 30 weeks)

Study Sites (1)

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