Status:
COMPLETED
Effects of Hyperbaric Oxygen Therapy on Children With Autism
Lead Sponsor:
Thoughtful House
Conditions:
Autism
Eligibility:
All Genders
2-10 years
Phase:
PHASE1
Brief Summary
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. ...
Detailed Description
Participants \& Setting Participants in this study will be 30 consecutive children referred to Thoughtful House for the treatment of autism or a related developmental disorder. Participants may or ma...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00406159
Start Date
November 1 2006
End Date
September 1 2007
Last Update
August 7 2009
Active Locations (1)
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1
Medical Center at Thoughtful House
Austin, Texas, United States, 78746