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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: Hyperbaric Oxygen Therapy

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).

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Brighton, Michigan, United States, 48116
      • Oxford Recovery Center
    • Troy, Michigan, United States, 48084
      • Oxford Recovery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The medical records were reviewed for children aged 2 - 17 years who were diagnosed by a qualified practitioner with autism spectrum disorder (ASD) and treated at the Oxford Recovery Center between Jan 2018 and July 2021. Each child who underwent a minimum of 40 hyperbaric oxygen treatments at 2.0 ATA in a hard sided monoplace chamber, had two age-appropriate verbal tests 6 months apart, and received applied behavioral analysis during the study period were included in the treatment group. Children who did not undergo hyperbaric oxygen therapy, received two age-appropriate verbal tests 6 months apart, and received applied behavioral analysis were included in the control group. Any child diagnosed with seizure disorder, genetic or mitochondrial mutation were excluded from the study cohort.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HBO Treatment Group; Children diagnosed with autism spectrum disorder received applied behavior therapy and hyperbaric oxygen therapy	Device: Hyperbaric 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
Control Group; Children diagnosed with autism spectrum disorder received applied behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Verbal testing: Verbal Behavior Milestones Assessment and Placement Program (VBMAPP)	Change from baseline of verbal scores at 6 months
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.	Verbal testing: Assessment of Basic Language and Learning Skills (ABLLS).	Change from baseline of verbal scores at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with hyperbaric oxygen treatment related adverse events.	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.	up to 30 weeks

Collaborators and Investigators

• Sponsor: Oxford Recovery Center
• Collaborators: The Oxford Center
• Investigators: Study Director: Robert Sherwin, MD, Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): February 20, 2022

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hyperbaric Oxygen Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: OxRS-01-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No