Clinical trial NCT00404846: Effects of Hyperbaric Oxygenation Therapy on Adaptive, Aberrant and Stereotyped Behaviors in Children With Autism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism
Keywords: Hyperbaric oxygenation therapy
HBOT
Autism
Lead sponsor: The Center for Autism and Related Disorders
Sponsor class: OTHER
Collaborators: name: The International Child Development Resource Center
First posted: 2006-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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)

Primary outcomes:
measure: Direct Behavioral Observations
measure: The Vineland Adaptive Behavior Scales: Expanded Edition (VABS)
measure: Peabody Picture Vocabulary Test (PPVT)
measure: Test of Visual-Perceptual Skills (TVPS)
measure: The Beery-Buktenica Developmental Test of Visual-Motor Integration (VMI)
measure: Autism Diagnostic Observation Schedule (ADOS)
measure: The Behavior Rating Inventory of Executive Functioning (BRIEF)
Secondary outcomes:
measure: Aberrant Behavior Checklist
measure: Clinical Global Impression Scale
Other outcomes:
Locations:
city: Tarzana
country: United States
facility: Center for Autism and Related Disorders
state: California
Study officials:
affiliation: ICDRC
name: Jeff Bradstreet, MD
role: PRINCIPAL_INVESTIGATOR
References: