Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism (HBOT)
August 1, 2012 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
- Age 3 to 8 years.
- Nonverbal IQ of 50 or above.
- Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 20 week intervention.
Exclusion Criteria:
- Clinical evidence of seizure disorder
- Active infection with fever
- Fragile X or other known genetic cause of autism
- Perinatal brain injury (e.g. cerebral palsy)
- Previous adequate trial (at least 20 session) of HBOT
- Inability to clear ears in the HBOT chambers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Active Hyperbaric Oxygen Treatment (HBOT)
|
1.5 ATA at 100% Oxygen of HBOT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score
Time Frame: 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.
|
Baseline, 8 Weeks from baseline, and 20 Weeks from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Robert L Hendren, DO, University of California, Davis - M.I.N.D. Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
December 22, 2007
First Submitted That Met QC Criteria
December 31, 2007
First Posted (Estimate)
January 2, 2008
Study Record Updates
Last Update Posted (Estimate)
August 7, 2012
Last Update Submitted That Met QC Criteria
August 1, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200715202-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.