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

May 1, 2009 updated by: The Center for Autism and Related Disorders
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Clinical Global Impression Scale
Aberrant Behavior Checklist

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Center for Autism and Related Disorders

Collaborators

The International Child Development Resource Center

Investigators

  • Principal Investigator: Jeff Bradstreet, MD, ICDRC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Anticipated)

December 1, 2007

Study Registration Dates

First Submitted

November 27, 2006

First Submitted That Met QC Criteria

November 27, 2006

First Posted (Estimate)

November 29, 2006

Study Record Updates

Last Update Posted (Estimate)

May 5, 2009

Last Update Submitted That Met QC Criteria

May 1, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 906001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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