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Effects of Hyperbaric Oxygen Therapy on Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00406159
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : August 7, 2009
Information provided by:
Thoughtful House

Brief Summary:


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.


  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.


  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.

Condition or disease Intervention/treatment Phase
Autism Device: Hyperbaric Oxygen Therapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Primary Outcome Measures :
  1. Standardized Measures
  2. 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:
  4. WPPSI-III (2-6 years) /WASI (6+ years)
  5. Vineland Adaptive Behavior Scale (VABS)
  6. Subjective Questionnaires
  7. Aberrant Behavior Checklist
  8. Clinical Global Impression
  9. ATEC
  10. Selected sections of the APEQ
  11. BRIEF
  12. Parenting Stress Index
  13. Repetitive Behavior Scale
  14. A side effect questionnaire
  15. Thoughtful House Caregiver diary

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00406159

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United States, Texas
Medical Center at Thoughtful House
Austin, Texas, United States, 78746
Sponsors and Collaborators
Thoughtful House
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Study Director: Andrew Wakefield, MD Thoughtful House Center for Children
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00406159    
Other Study ID Numbers: 06.10.0004
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: August 2009
Keywords provided by Thoughtful House:
Hyperbaric Oxygen Therapy
Behavioral assessments
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders