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

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Device: Hyperbaric Oxygen Therapy

• Registration Number: NCT06043284
• Lead Sponsor: Oxford Recovery Center

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).

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2021-07-31
• Study Completion: 2022-02-20
• Study First Submitted: 2023-06-05
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HBO Treatment Group	Hyperbaric Oxygen Therapy	Children diagnosed with autism spectrum disorder received applied behavior therapy and hyperbaric oxygen therapy

Primary Outcome Measures

Name	Time	Method
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.	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.	Change from baseline of verbal scores at 6 months	Verbal testing: Assessment of Basic Language and Learning Skills (ABLLS).

Secondary Outcome Measures

Name	Time	Method
Number of participants with hyperbaric oxygen treatment related adverse events.	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.

Trial Locations

Locations (1)

Oxford Recovery Center; 🇺🇸 Troy, Michigan, United States