Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism
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.
Condition:
Autism
Treatment:
Hyperbaric Oxygen Treatment (HBOT)
Start Date:
October 2007
Sponsor:
University of California, San Francisco
For More Information:
https://clinicaltrials.gov/show/NCT00584480