Effects of Hyperbaric Oxygen Therapy on Children With Autism
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|ClinicalTrials.gov Identifier: NCT00406159|
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : August 7, 2009
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.
- Hyperbaric Oxygenation Therapy will be safe to use with children with autism.
- Hyperbaric Oxygenation Therapy will have a statistically significant effect on the symptoms of autism.
- Hyperbaric Oxygenation Therapy will have a clinically significant observable effect on the overt symptoms of autism.
- The decreases in the symptoms of autism will correlate positively with the number of Hyperbaric Oxygenation Therapy sessions.
- Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up, post 40 treatment sessions.
- Provide further evidence for the safety of Hyperbaric Oxygenation Therapy in children with autism.
- To quantitatively assess the effects of Hyperbaric Oxygenation Therapy on behavioral and cognitive symptoms of autism before, during, and after treatment.
- Identify number of treatments required to reach therapeutic effects.
- Identify the length and durability of treatment effect and maintenance.
|Condition or disease||Intervention/treatment||Phase|
|Autism||Device: Hyperbaric Oxygen Therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Hyperbaric Oxygen Therapy on Behavioral Measures of Short Term Memory, Learning, and Behavior in Children With Autism|
|Study Start Date :||November 2006|
|Actual Study Completion Date :||September 2007|
- Standardized Measures
- In addition to the direct measures of behavior described above, standardized intelligence and adaptive assessments will be conducted prior to the initiation of HBOT. These will include:
- WPPSI-III (2-6 years) /WASI (6+ years)
- Vineland Adaptive Behavior Scale (VABS)
- Subjective Questionnaires
- Aberrant Behavior Checklist
- Clinical Global Impression
- Selected sections of the APEQ
- Parenting Stress Index
- Repetitive Behavior Scale
- A side effect questionnaire
- Thoughtful House Caregiver diary
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406159
|United States, Texas|
|Medical Center at Thoughtful House|
|Austin, Texas, United States, 78746|
|Study Director:||Andrew Wakefield, MD||Thoughtful House Center for Children|