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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06043284
• Other study ID #: OxRS-01-2021
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: February 20, 2022

Study information

• Verified date: September 2023
• Source: Oxford Recovery Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 20, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Oxford Recovery Center	Brighton	Michigan
United States	Oxford Recovery Center	Troy	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Oxford Recovery Center	The Oxford Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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