effects of hyperbaric oxygenation therapy on adaptive, aberrant and stereotyped behaviors in children with autism

Conditions: Autism

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.

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 criteria:
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)

Keywords: hyperbaric oxygenation therapy hbot autism