Effects of Hyperbaric Oxygenation Therapy on Adaptive, Aberrant and Stereotyped Behaviors in Children With Autism
- Conditions
- Autism
- Registration Number
- NCT00404846
- Lead Sponsor
- The Center for Autism and Related Disorders
- 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 and other developmental disabilities.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Autism diagnosis
- Access to CARD clinics as necessary for the study duration
- Caregiver commitment to completing 80 sessions in 10-15 weeks
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method Aberrant Behavior Checklist Clinical Global Impression Scale
Trial Locations
- Locations (1)
Center for Autism and Related Disorders
🇺🇸Tarzana, California, United States