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

Sponsor

Oxford Recovery Center (Other)

Overall Status

Completed

CT.gov ID

NCT06043284

Collaborator

The Oxford Center (Other)

Enrollment

Locations

49.6

Actual Duration (Months)

32.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	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 Design

Study Type:

Observational

Actual Enrollment :

65 participants

Observational Model:

Other

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Feb 20, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oxford Recovery Center	Brighton	Michigan	United States	48116
2	Oxford Recovery Center	Troy	Michigan	United States	48084

Sponsors and Collaborators

Oxford Recovery Center
The Oxford Center

Investigators

Study Director: Robert Sherwin, MD, Wayne State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tami Peterson PhD, Principal Investigator, Oxford Recovery Center

ClinicalTrials.gov Identifier:

NCT06043284

Other Study ID Numbers:

OxRS-01-2021

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Tami Peterson PhD, Principal Investigator, Oxford Recovery Center

Hyperbaric Oxygen Therapy

Additional relevant MeSH terms:

Autism Spectrum Disorder

Study Results

No Results Posted as of Sep 21, 2023