Overview

This trial is active, not recruiting.

Condition autism
Treatment hyperbaric oxygenation therapy
Sponsor The Center for Autism and Related Disorders
Collaborator The International Child Development Resource Center
Start date November 2006
End date September 2007
Trial size 40 participants
Trial identifier NCT00404846, 906001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Direct Behavioral Observations
time frame:
The Vineland Adaptive Behavior Scales: Expanded Edition (VABS)
time frame:
Peabody Picture Vocabulary Test (PPVT)
time frame:
Test of Visual-Perceptual Skills (TVPS)
time frame:
The Beery-Buktenica Developmental Test of Visual-Motor Integration (VMI)
time frame:
Autism Diagnostic Observation Schedule (ADOS)
time frame:
The Behavior Rating Inventory of Executive Functioning (BRIEF)
time frame:

Secondary Outcomes

Measure
Aberrant Behavior Checklist
time frame:
Clinical Global Impression Scale
time frame:

Eligibility Criteria

Male or female participants from 2 years up to 14 years old.

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)

Additional Information

Principal investigator Jeff Bradstreet, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by The Center for Autism and Related Disorders.