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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
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The purpose of this study is to increase the understanding of the effect of Hyperbaric Oxygen Treatment (HBOT) on the behavior and functioning of children with autism. The main goal of this study is to demonstrate that HBOT is safe and tolerable in autistic children, and to measure the effect of HBOT on specific chemicals in their blood that may play a role in the child's behavior.
During the study's 20-week duration, all children will receive Hyperbaric Oxygen Treatment (HBOT) for two eight-week sessions, with a four week session between. Therefore, all children will participate in the study for 20 weeks, and will receive HBOT for 16 weeks. This is an open label study. This means that there will not be a placebo group in the study. All study participants will receive the same treatment of HBOT in a hard shell chamber. Normal air contains about 24% oxygen at a pressure of about 1 atmosphere absolute (ATA). The chamber will contain 100 percent oxygen at a pressure of 1.5 ATA, which is equivalent to the pressure at a depth of 15 feet in sea water. Each subject will complete the first 40 treatments during one hour sessions on 5 separate days in each of the first 8 weeks. They will then take a 4-week break before they begin their next 40 treatments, which will also occur during one hour sessions on 5 separate days in each of the last 8 weeks. The entire study will last 20 weeks. The child's behavior will be measured and evaluated at the MIND Institute at the beginning of the study, at week 8, and at week 20.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Active Hyperbaric Oxygen Treatment (HBOT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen Treatment (HBOT) | Other | 1.5 ATA at 100% Oxygen of HBOT |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score | Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved. | Baseline, 8 Weeks from baseline, and 20 Weeks from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert L Hendren, DO | University of California, Davis - M.I.N.D. Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21818676 | Derived | Bent S, Bertoglio K, Ashwood P, Nemeth E, Hendren RL. Brief report: Hyperbaric oxygen therapy (HBOT) in children with autism spectrum disorder: a clinical trial. J Autism Dev Disord. 2012 Jun;42(6):1127-32. doi: 10.1007/s10803-011-1337-3. |
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Enrollment took place between October 1, 2007 to April 24, 2009. Children between the ages of 3 and 8 with a diagnosis of Autism Spectrum Disorders (ASD) were recruited from the outpatient autism clinic at the MIND Institute (University of California, Davis).
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyperbaric Oxygen Treatment (HBOT) | Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 8 Weeks (40 Treatments) |
| |||||||||||||
| 4-Week Break From Treatment |
| |||||||||||||
| Second 8 Weeks (40 Treatments) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyperbaric Oxygen Treatment (HBOT) | Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score | Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved. | Posted | Number | participants | Baseline, 8 Weeks from baseline, and 20 Weeks from baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyperbaric Oxygen Treatment (HBOT) | Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Likely not related to HBOt treatment. Only ear pain, increased fatigue, dehydration, and increased mouthing of objects were judged to be likely related to the HBOT treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Discomfort | Ear and labyrinth disorders |
1) Small sample size 2) Lack of control group prevented an examination of whether changes in clinical measure of disease severity were due to HBOT or other factors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert L. Hendren, D.O. | UCSF | 415-476-7198 | Robert.Hendren@ucsf.edu |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 1 |
| 10 |
| 5 |
| 10 |
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| Ear Infection | Ear and labyrinth disorders |
|
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