Effects of Hyperbaric Oxygenation Therapy on Adaptive, Aberrant and Stereotyped Behaviors in Children With Autism
Recruitment status was Active, not recruiting
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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 and other developmental disabilities.
| Condition | Intervention |
|---|---|
|
Autism |
Procedure: Hyperbaric Oxygenation Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
- Direct Behavioral Observations
- The Vineland Adaptive Behavior Scales: Expanded Edition (VABS)
- Peabody Picture Vocabulary Test (PPVT)
- Test of Visual-Perceptual Skills (TVPS)
- The Beery-Buktenica Developmental Test of Visual-Motor Integration (VMI)
- Autism Diagnostic Observation Schedule (ADOS)
- The Behavior Rating Inventory of Executive Functioning (BRIEF)
- Aberrant Behavior Checklist
- Clinical Global Impression Scale
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | December 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Positive treatment effects of HBOT have been reported in a number of studies, while others have found no demonstrable effect. Studies to date have evaluated effects on a variety of conditions, and utilized diverse research methods and generally await replication. Despite its increasing usage in children with autism, and the preliminary anecdotal reports indicating positive outcome, there is a paucity of well-controlled studies of HBOT in this population, which precludes clinicians from recommending and/or implementing it as an evidence-based treatment. It is clearly important therefore, to evaluate carefully the treatment effects of HBOT using robust research designs in this population.
Hypotheses
- Hyperbaric Oxygenation Therapy will be associated with a positive effect on symptoms of autism.
- Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up.
Specific Aims
- Evaluate the effects of Hyperbaric Oxygenation Therapy on behavioral and cognitive symptoms of autism before, during, and after treatment.
- Determine the percentage of children with autism who respond positively to 80 HBOT treatment cycles and the extent to which they do so.
- Determine the extent to which any observed treatment effects are maintained up to three months after HBOT.
Study duration: Two weeks baseline, 10-15 week acute phase, with 1- and 3-month follow-ups.
All participants will spend one hour per session in hyperbaric oxygen chambers, for a minimum of 6 and a maximum of 10 sessions per week. A total of 80 cycles of one hour compressions must be completed within 15 weeks for all participants
Treatment Group: Pressure and Frequency
- 1.3 atmosphere absolute (ATA)
- 24% oxygen
- One session = 1 hour
- Total of 80 cycles of one hour compressions must be completed within 15 weeks.
Placebo Group: Pressure and Frequency
- Close to ambient air pressure, but the chamber needs enough pressure to inflate: 1.05 to 1.1 atmosphere absolute (ATA)
- Room Air
- One session = 1 hour
- Total of 80 cycles of one hour compressions must be completed within 15 weeks.
Eligibility| Ages Eligible for Study: | 2 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Autism diagnosis
- Access to CARD clinics as necessary for the study duration
- Caregiver commitment to completing 80 sessions in 10-15 weeks
Exclusion Criteria:
- Any prior treatment with HBOT
- New dietary treatment within 3 months prior to enrollment,
- New biomedical treatment within 3 weeks prior to enrollment
- Inadequate vision or hearing for the purposes of test administration
- Non-ambulatory or require more than minimum support walking
- Unstable medical disorder
- History of, or current seizure disorder
- History of, or current asthma
- History of, or current pulmonary cysts
- History of, or current emphysema
- History of, or current severe claustrophobia
- Current otitis media
- Current sinus infection
- Current upper respiratory tract infection (URTI)
Contacts and Locations| United States, California | |
| Center for Autism and Related Disorders | |
| Tarzana, California, United States, 91356 | |
| Principal Investigator: | Jeff Bradstreet, MD | ICDRC |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00404846 History of Changes |
| Other Study ID Numbers: | 906001 |
| Study First Received: | November 27, 2006 |
| Last Updated: | May 1, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Center for Autism and Related Disorders:
|
Hyperbaric oxygenation therapy HBOT Autism |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013