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

NCT ID: NCT06043284

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-02-20

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).

Conditions

Autism Spectrum Disorder

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

HBO Treatment Group

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

Hyperbaric Oxygen Therapy

Intervention Type: DEVICE

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

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Oxford Center

UNKNOWN

Sponsor Role: collaborator

Oxford Recovery Center

OTHER

Sponsor Role: lead

Responsible Party

Tami Peterson PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Sherwin, MD

Role: STUDY_DIRECTOR

Wayne State University

Locations

Oxford Recovery Center

Brighton, Michigan, United States

Oxford Recovery Center

Troy, Michigan, United States

Countries

United States

Other Identifiers

OxRS-01-2021

Identifier Type: -

Identifier Source: org_study_id