AutismNCT00404846
Effects of Hyperbaric Oxygenation Therapy on Adaptive, Aberrant and Stereotyped Behaviors in Children With Autism
A study testing Hyperbaric Oxygenation Therapy in people with Autism, run by The Center for Autism and Related Disorders at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Autism
- What is being tested?
- Hyperbaric Oxygenation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Autism diagnosis
- Access to CARD clinics as necessary for the study duration
- Caregiver commitment to completing 80 sessions in 10-15 weeks
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Autism and Related Disorders
Tarzana, California, 91356
About this study
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.
Read the 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.
- Conditions
- Autism
- Being tested
- Hyperbaric Oxygenation Therapy
- Keywords
- Hyperbaric oxygenation therapy, HBOT, Autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygenation TherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
Aberrant Behavior Checklist
Clinical Global Impression Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2007
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Center for Autism and Related Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- The International Child Development Resource Center
- Investigators
- Jeff Bradstreet, MD, Principal investigator, ICDRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404846
- Sponsor's protocol ID
- 906001
- Status last verified
- May 2009
- First submitted
- 27 Nov 2006
- Last updated
- 5 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hyperbaric Oxygenation Therapy on Adaptive, Aberrant and Stereotyped Behaviors in Children With Autism
- ClinicalTrials.gov ID
- NCT00404846
- Acronym / sponsor ID
- 906001
- Conditions
- Autism
- Keywords
- Hyperbaric oxygenation therapy, HBOT, Autism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Center for Autism and Related DisordersUniversity, hospital or other
- Collaborators
- The International Child Development Resource Center
- Study start
- Nov 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2007 (estimated)
- First posted
- 29 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Autism diagnosis
- Access to CARD clinics as necessary for the study duration
- Caregiver commitment to completing 80 sessions in 10-15 weeks
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygenation Therapy | Procedure or surgery | – |
Primary outcome
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)
2 secondary outcomes
Aberrant Behavior Checklist
Clinical Global Impression Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2009.
- Center for Autism and Related Disorders HomepageLink provided by the sponsor.
- International Child Development Resource Center HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Bradstreet, MD principal investigator
ICDRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygenation Therapy in people with Autism, run by The Center for Autism and Related Disorders at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct Behavioral Observations. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2009.