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

Autism Clinical Trial

— HBOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584480
• Other study ID #: 200715202-1
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2007
• Last updated: August 1, 2012
• Start date: October 2007
• Est. completion date: September 2009

Study information

• Verified date: August 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 8 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Other:
• Hyperbaric Oxygen Treatment (HBOT)
1.5 ATA at 100% Oxygen of HBOT

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score	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.	Baseline, 8 Weeks from baseline, and 20 Weeks from baseline	No