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Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism (HBOT)

This study has been completed.
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00584480
First received: December 22, 2007
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to increase the understanding of the effect of Hyperbaric Oxygen Treatment (HBOT) on the behavior and functioning of children with autism. The main goal of this study is to demonstrate that HBOT is safe and tolerable in autistic children, and to measure the effect of HBOT on specific chemicals in their blood that may play a role in the child's behavior.


Condition Intervention Phase
Autism
 Other: Hyperbaric Oxygen Treatment (HBOT)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score [ Time Frame: Baseline, 8 Weeks from baseline, and 20 Weeks from baseline ] [ Designated as safety issue: No ]
    Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved.


Enrollment: 10
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Active Hyperbaric Oxygen Treatment (HBOT)
 Other: Hyperbaric Oxygen Treatment (HBOT)
1.5 ATA at 100% Oxygen of HBOT

Detailed Description:

During the study's 20-week duration, all children will receive Hyperbaric Oxygen Treatment (HBOT) for two eight-week sessions, with a four week session between. Therefore, all children will participate in the study for 20 weeks, and will receive HBOT for 16 weeks. This is an open label study. This means that there will not be a placebo group in the study. All study participants will receive the same treatment of HBOT in a hard shell chamber. Normal air contains about 24% oxygen at a pressure of about 1 atmosphere absolute (ATA). The chamber will contain 100 percent oxygen at a pressure of 1.5 ATA, which is equivalent to the pressure at a depth of 15 feet in sea water. Each subject will complete the first 40 treatments during one hour sessions on 5 separate days in each of the first 8 weeks. They will then take a 4-week break before they begin their next 40 treatments, which will also occur during one hour sessions on 5 separate days in each of the last 8 weeks. The entire study will last 20 weeks. The child's behavior will be measured and evaluated at the MIND Institute at the beginning of the study, at week 8, and at week 20.

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of DSM-IV defined autism and meets cut off for autism on the Autism Diagnostic Inventory-Revised (ADI-R) or Social Communication Questionnaire (SCQ) and the Autism Diagnostic Observation Scale (ADOS).
  2. Age 3 to 8 years.
  3. Nonverbal IQ of 50 or above.
  4. Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 20 week intervention.

Exclusion Criteria:

  1. Clinical evidence of seizure disorder
  2. Active infection with fever
  3. Fragile X or other known genetic cause of autism
  4. Perinatal brain injury (e.g. cerebral palsy)
  5. Previous adequate trial (at least 20 session) of HBOT
  6. Inability to clear ears in the HBOT chambers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584480

Sponsors and Collaborators
University of California, San Francisco
University of California, Davis
Investigators
Principal Investigator: Robert L Hendren, DO University of California, Davis - M.I.N.D. Institute
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00584480     History of Changes
Other Study ID Numbers: 200715202-1
Study First Received: December 22, 2007
Results First Received: September 13, 2011
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013