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.
Condition:
Autism
Treatment:
Hyperbaric Oxygenation Therapy
Start Date:
November 2006
Sponsor:
The Center for Autism and Related Disorders
For More Information:
https://clinicaltrials.gov/show/NCT00404846