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

NCT ID: NCT00404846

Last Updated: 2009-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2007-12-31

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.

Conditions

Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Hyperbaric Oxygenation Therapy

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The International Child Development Resource Center

OTHER

Sponsor Role: collaborator

The Center for Autism and Related Disorders

OTHER

Sponsor Role: lead

Principal Investigators

Jeff Bradstreet, MD

Role: PRINCIPAL_INVESTIGATOR

ICDRC

Locations

Center for Autism and Related Disorders

Tarzana, California, United States

Countries

United States

Related Links

http://www.centerforautism.com

Center for Autism and Related Disorders Homepage

http://www.icdrc.org/

International Child Development Resource Center Homepage

Other Identifiers

906001

Identifier Type: -

Identifier Source: org_study_id