Autism
Conditions
Brief summary
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.
Detailed description
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.
Interventions
1.5 ATA at 100% Oxygen of HBOT
Sponsors
University of California, Davis
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of DSM-IV defined autism and meets cut off for autism on the Autism Diagnostic Inventory-Revised (ADI-R) or Social Communication Questionnaire (SCQ) and the Autism Diagnostic Observation Scale (ADOS). 2. Age 3 to 8 years. 3. Nonverbal IQ of 50 or above. 4. Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 20 week intervention.
Exclusion criteria
1. Clinical evidence of seizure disorder 2. Active infection with fever 3. Fragile X or other known genetic cause of autism 4. Perinatal brain injury (e.g. cerebral palsy) 5. Previous adequate trial (at least 20 session) of HBOT 6. Inability to clear ears in the HBOT chambers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score | Baseline, 8 Weeks from baseline, and 20 Weeks from baseline | 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. |
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Hyperbaric Oxygen Treatment (HBOT) |
|---|---|
| Age, Categorical <=18 years | 10 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 5.3 years STANDARD_DEVIATION 1.8 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
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.
Time frame: Baseline, 8 Weeks from baseline, and 20 Weeks from baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hyperbaric Oxygen Treatment (HBOT) | Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score | CGI-I Score of exactly 1 at 40 days | 5 participants |
| Hyperbaric Oxygen Treatment (HBOT) | Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score | CGI-I Score of exactly 2 at 40 days | 5 participants |
| Hyperbaric Oxygen Treatment (HBOT) | Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score | CGI-I Score of exactly 2 at 80 days | 10 participants |