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

Autism Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00404846
• Other study ID #: 906001
• Status: Active, not recruiting
• Phase: N/A
• First received: November 27, 2006
• Last updated: May 1, 2009
• Start date: November 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2009
• Source: The Center for Autism and Related Disorders
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism

Intervention

Procedure:
• Hyperbaric Oxygenation Therapy

Locations

Country	Name	City	State
United States	Center for Autism and Related Disorders	Tarzana	California

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Autism and Related Disorders	The International Child Development Resource Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direct Behavioral Observations
Primary	The Vineland Adaptive Behavior Scales: Expanded Edition (VABS)
Primary	Peabody Picture Vocabulary Test (PPVT)
Primary	Test of Visual-Perceptual Skills (TVPS)
Primary	The Beery-Buktenica Developmental Test of Visual-Motor Integration (VMI)
Primary	Autism Diagnostic Observation Schedule (ADOS)
Primary	The Behavior Rating Inventory of Executive Functioning (BRIEF)
Secondary	Aberrant Behavior Checklist
Secondary	Clinical Global Impression Scale

External Links

•   Center for Autism and Related Disorders Homepage
•   International Child Development Resource Center Homepage