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

NCT06043284 | Completed FDA Device

• 1 other identifier: OxRS-01-2021
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Keywords

Hyperbaric Oxygen Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  up to 30 weeks

Study Arms (2)

HBO Treatment Group

Children diagnosed with autism spectrum disorder received applied behavior therapy and hyperbaric oxygen therapy

Device: Hyperbaric Oxygen Therapy

Control Group

Children diagnosed with autism spectrum disorder received applied behavioral therapy

Interventions

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

HBO Treatment Group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oxford Recovery Center: lead
• The Oxford Center: collaborator

Study Sites (2)

Oxford Recovery Center

Brighton, Michigan, 48116, United States

Location

Oxford Recovery Center

Troy, Michigan, 48084, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Robert Sherwin, MD

  Wayne State University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: September 21, 2023
• Study Start: January 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: February 20, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)