AutismNCT00263367
Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism
A study testing Hyperbaric Oxygen in people with Autism and Oxidative Stress, run by The International Child Development Resource Center at 1 site in United States.
Trial summary
This study will look at the changes taking place in the blood levels of key markers of oxidative stress. Oxidative stress is the biological equivalent of rust on a car. It changes vital cell chemistry. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Autism, Oxidative Stress
- What is being tested?
- Hyperbaric Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Feb 2006
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with autism ages 5-12 and undergoing hyperbarics
Who cannot join
- Seizures, acute URI, or inability to ventilate ears
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism: A Pilot Study
This study will look at the changes taking place in the blood levels of key markers of oxidative stress. Oxidative stress is the biological equivalent of rust on a car. It changes vital cell chemistry. It is known to occur at high pressure oxygen, but little is known about changes at pressures slightly greater than normal atmospheric pressure.
Hyperbaric therapy is used in a variety of medical conditions. It is being tested in this study only for safety. It is not being assessed for the ability of hyperbaric oxygen to improve the clinical condition of children with autism.
This study was felt to be important since autism appears to be associated with oxidative stress and hyperbarics was being used "off-label" for this condition without safety studies.
Read the detailed description
Blood will be drawn immediately prior to a one hour session of hyperbarics (HBT. A catheter will be inserted in to a vein and converted to a heparin lock indwelling port for the next blood draw. The child (ages 5-12 years) will then undergo 1 hour of compression at 1.3 atmospheric pressure (4 psi above room air pressure). Supplemental oxygen will be provided to the child.
A second blood draw from the catheter site will be accomplished immediately after the child comes out of the HBT chamber.
These will be sent to the laboratories for evaluation of changes in reduced glutathione and lipid peroxides.
- Conditions
- Autism, Oxidative Stress
- Being tested
- Hyperbaric Oxygen
- Keywords
- Autism, Oxidative Stress, Hyperbaric Oxygen, Reduced Glutathione, Lipid Peroxides
- 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 OxygenOther
Also called HBOT
Hyperbaric Oxygen at 1.3 ATA for one hour
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric oxygen at 1.3 ATA | Other | Hyperbaric Oxygen at 1.3 ATA for one hour followed by measurement of glutathione in the blood Receives: Other: Hyperbaric Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
glutathione
measurement of glutathione immediately after one hour of exposure to low dose HBOT
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2005 (estimated)
- Study startOct 2005
- Primary completionJan 2006
- Study completionFeb 2006
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The International Child Development Resource Center
- Sponsor type
- University, hospital or other
- Investigators
- James J Bradstreet, MD FAAFP, Principal investigator, ICDRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263367
- Sponsor's protocol ID
- ICDRC-22.2005
- Status last verified
- Jun 2011
- First submitted
- 21 Nov 2005
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism: A Pilot Study
- ClinicalTrials.gov ID
- NCT00263367
- Acronym / sponsor ID
- ICDRC-22.2005
- Conditions
- Autism, Oxidative Stress
- Keywords
- Autism, Oxidative Stress, Hyperbaric Oxygen, Reduced Glutathione, Lipid Peroxides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The International Child Development Resource CenterUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 8 Dec 2005 (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.
This study will look at the changes taking place in the blood levels of key markers of oxidative stress. Oxidative stress is the biological equivalent of rust on a car. It changes vital cell chemistry. It is known to occur at high pressure oxygen, but little is known about changes at pressures slightly greater than normal atmospheric pressure.
Hyperbaric therapy is used in a variety of medical conditions. It is being tested in this study only for safety. It is not being assessed for the ability of hyperbaric oxygen to improve the clinical condition of children with autism.
This study was felt to be important since autism appears to be associated with oxidative stress and hyperbarics was being used "off-label" for this condition without safety studies.
Detailed description
Blood will be drawn immediately prior to a one hour session of hyperbarics (HBT. A catheter will be inserted in to a vein and converted to a heparin lock indwelling port for the next blood draw. The child (ages 5-12 years) will then undergo 1 hour of compression at 1.3 atmospheric pressure (4 psi above room air pressure). Supplemental oxygen will be provided to the child.
A second blood draw from the catheter site will be accomplished immediately after the child comes out of the HBT chamber.
These will be sent to the laboratories for evaluation of changes in reduced glutathione and lipid peroxides.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen at 1.3 ATA | Other | Other: Hyperbaric OxygenHyperbaric Oxygen at 1.3 ATA for one hour followed by measurement of glutathione in the blood |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children diagnosed with autism ages 5-12 and undergoing hyperbarics
Key exclusion criteria (1 listed)
- Seizures, acute URI, or inability to ventilate ears
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 OxygenAlso: HBOTHyperbaric Oxygen at 1.3 ATA for one hour | Other | hyperbaric oxygen at 1.3 ATA |
Primary outcome
glutathione
Time frame: 1 hour
measurement of glutathione immediately after one hour of exposure to low dose HBOT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
- Primary LocationLink 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.
James J Bradstreet, MD FAAFP 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 Oxygen in people with Autism and Oxidative Stress, run by The International Child Development Resource Center 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jun 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
glutathione (time frame: 1 hour). 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 22 Jun 2011.