Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism (HBOT)
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism|
- 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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Active Hyperbaric Oxygen Treatment (HBOT)
Other: Hyperbaric Oxygen Treatment (HBOT)
1.5 ATA at 100% Oxygen of HBOT
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.