Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Oxford Center | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBO Treatment Group | Children diagnosed with autism spectrum disorder received applied behavior therapy and hyperbaric oxygen therapy |
| |
| Control Group | Children diagnosed with autism spectrum disorder received applied behavioral therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Sherwin, MD | Wayne State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Recovery Center | Brighton | Michigan | 48116 | United States | ||
| Oxford Recovery Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
| Troy |
| Michigan |
| 48084 |
| United States |