Effects of Hyperbaric Oxygen Therapy on Children With Autism

Completed · Phase 1

Conditions studied: Autism

In brief

PURPOSE The purpose of this investigation is to evaluate the cognitive and behavioral effects of Hyperbaric Oxygenation Therapy in children who present with a diagnosis of autism spectrum disorder. HYPOTHESIS 1. Hyperbaric Oxygenation Therapy will be safe to use with children with autism. 2. Hyperbaric Oxygenation Therapy will have a statistically significant effect on the symptoms of autism. 3. Hyperbaric Oxygenation Therapy will have a clinically significant observable effect on the overt symptoms of autism. 4. The decreases in the symptoms of autism will correlate positively with the number of Hyperbaric Oxygenation Therapy sessions. 5. Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up, post 40 treatment sessions. SPECIFIC AIMS 1. Provide further evidence for the safety of Hyperbaric Oxygenation Therapy in children with autism. 2. To quantitatively assess the effects of Hyperbaric Oxygenation Therapy on behavioral and cognitive symptoms of autism before, during, and after treatment. 3. Identify number of treatments required to reach therapeutic effects. 4. Identify the length and durability of treatment effect and maintenance.

Key facts

Study ID

NCT00406159

Run by

Thoughtful House

People needed

30

Starts

2006-11-01

Expected to finish

2007-09-01

Last updated by the study team

2009-08-07

Who can join

Age: 2 and older, up to 10. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female children 2-10 years diagnosed with autism, PDD, or Aspergers
• No anticipated changes in treatment for the study duration (e.g., diet, nutrients)
• No additional biomedical treatments started 6 weeks prior to enrollment
• No changes in dietary management for 3 months prior to enrollment
• Access to Thoughtful House on a daily basis, or as necessary for the study participation
• In addition, the child participant must be:
• Ambulatory or require minimum support walking, per parent
• Able to sit still for 5 minutes or longer with a preferred toy item, per parent
• Adequate vision and hearing for the purposes of test administration, per parent
• Adequate arm-hand-finger coordination (i.e., able to point) for learning and cognitive tasks used in outcome measurement, per parent
• Stable and controlled medical disorder
• Under the care of a caregiver willing to participate by attending regularly scheduled appointments and completing the necessary measures

Where it is running

• Medical Center at Thoughtful House — Austin, Texas, United States

Full record on ClinicalTrials.gov

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