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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by The Center for Autism and Related Disorders.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The International Child Development Resource Center
Information provided by:
The Center for Autism and Related Disorders
ClinicalTrials.gov Identifier:
NCT00404846
First received: November 27, 2006
Last updated: May 1, 2009
Last verified: May 2009
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Resource Center
Investigators
Principal Investigator: Jeff Bradstreet, MD ICDRC
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00404846     History of Changes
Other Study ID Numbers: 906001
Study First Received: November 27, 2006
Last Updated: May 1, 2009
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:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on November 25, 2014