Effects of Hyperbaric Oxygenation Therapy on Adaptive, Aberrant and Stereotyped Behaviors in Children With Autism

The Center for Autism and Related Disorders

Status: Unknown

Conditions: Autism

Treatments: Procedure: Hyperbaric Oxygenation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00404846

906001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind