Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism

Study Overview
=================
Brief Summary
-----------------
This study will look at the changes taking place in the blood levels of key markers of oxidative stress. Oxidative stress is the biological equivalent of rust on a car. It changes vital cell chemistry. It is known to occur at high pressure oxygen, but little is known about changes at pressures slightly greater than normal atmospheric pressure. Hyperbaric therapy is used in a variety of medical conditions. It is being tested in this study only for safety. It is not being assessed for the ability of hyperbaric oxygen to improve the clinical condition of children with autism. This study was felt to be important since autism appears to be associated with oxidative stress and hyperbarics was being used off-label for this condition without safety studies.

Detailed Description
-----------------
Blood will be drawn immediately prior to a one hour session of hyperbarics (HBT. A catheter will be inserted in to a vein and converted to a heparin lock indwelling port for the next blood draw. The child (ages 5-12 years) will then undergo 1 hour of compression at 1.3 atmospheric pressure (4 psi above room air pressure). Supplemental oxygen will be provided to the child. A second blood draw from the catheter site will be accomplished immediately after the child comes out of the HBT chamber. These will be sent to the laboratories for evaluation of changes in reduced glutathione and lipid peroxides.

Official Title
-----------------
Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism: A Pilot Study

Conditions
-----------------
Autism, Oxidative Stress

Intervention / Treatment
-----------------
* Other: Hyperbaric Oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children diagnosed with autism ages 5-12 and undergoing hyperbarics Exclusion Criteria: Seizures, acute URI, or inability to ventilate ears

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hyperbaric oxygen at 1.3 ATA<br>Hyperbaric Oxygen at 1.3 ATA for one hour followed by measurement of glutathione in the blood | Other: Hyperbaric Oxygen<br>* Hyperbaric Oxygen at 1.3 ATA for one hour<br>* Other names: HBOT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glutathione | measurement of glutathione immediately after one hour of exposure to low dose HBOT | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism, Oxidative Stress, Hyperbaric Oxygen, Reduced Glutathione, Lipid Peroxides