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

Sponsor:	The Center for Autism and Related Disorders
Collaborator:	The International Child Development Resrouce Center
Information provided by:	The Center for Autism and Related Disorders
ClinicalTrials.gov Identifier:	NCT00404846

Purpose

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.

Condition	Intervention
Autism	Procedure: Hyperbaric Oxygenation Therapy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Autism

U.S. FDA Resources

Further study details as provided by The Center for Autism and Related Disorders:

Primary Outcome Measures:

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:

Aberrant Behavior Checklist
Clinical Global Impression Scale

Estimated Enrollment:	40
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	2 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404846

Locations

United States, California
Center for Autism and Related Disorders
Tarzana, California, United States, 91356

Sponsors and Collaborators

The Center for Autism and Related Disorders

The International Child Development Resrouce Center

Investigators

Principal Investigator:

Jeff Bradstreet, MD

ICDRC

More Information

Additional Information:

Center for Autism and Related Disorders Homepage This link exits the ClinicalTrials.gov site

International Child Development Resource Center Homepage This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	906001
Study First Received:	November 27, 2006
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00404846 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The Center for Autism and Related Disorders:

Hyperbaric oxygenation therapy
HBOT
Autism

Additional relevant MeSH terms:

Child Development Disorders, Pervasive
Mental Disorders
Autistic Disorder
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on November 05, 2009