CognitionNCT00631215
Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children
A study testing Hyperbaric oxygen therapy in people with Cognition, run by Pediatric Partners of Ponte Vedra at 1 site in United States.
Trial summary
HYPOTHESIS 1. Hyperbaric Oxygenation Therapy will be safe to use with neurotypical adults and children. 2. Hyperbaric Oxygenation Therapy will have a statistically significant positive effect on measures of cognitive function in neurotypical adults and children. 3. Read more about this study
- Who is it for?
- Ages 6 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- Hyperbaric oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Oct 2009
- 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 6 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Males and females from 6 to 75 years of age with typical cognitive function and no neurologic or psychological diagnoses potentially impairing cognitive function
- No anticipated changes in treatment for the study duration (e.g., diet, nutrients)
- No additional biomedical treatments started 6 weeks prior to enrollment
- No changes in dietary management for 3 months prior to enrollment
- Access to Pediatric Partners on a daily basis, or as necessary for the study participation
- In addition, the participant must be:
Show all 14Show fewer
- Ambulatory or require minimum support walking
- Able to sit still for 12 minutes or longer for the purposes of test administration
- Adequate vision and hearing for the purposes of test administration, per parent
- Able to read and understand basic instructions
- Adequate arm-hand-finger coordination for computer use in outcome measurement
- Medical disorders, if present, must be stable and controlled
- Willing to participate by attending regularly scheduled appointments and completing the necessary measures
- Previous exposure to hyperbaric oxygen therapy
Who cannot join
- Current otitis media Sinus infection Asthma Pulmonary cysts Emphysema Upper respiratory infection Severe claustrophobia, intolerance to being in the chamber Unstable/uncontrolled disorder of any kind
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Pediatric Partners of Ponte Vedra
Ponte Vedra Beach, Florida, 32082
Laurie Thomas, BA, 904-543-1288 ext. 10, laurie@pppvonline.com
Jerry J Kartzinel, MD
About this study
HYPOTHESIS
- Hyperbaric Oxygenation Therapy will be safe to use with neurotypical adults and children.
- Hyperbaric Oxygenation Therapy will have a statistically significant positive effect on measures of cognitive function in neurotypical adults and children.
- The improvement in cognitive function will correlate positively with the number of Hyperbaric Oxygenation Therapy sessions.
- Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up, post 40 treatment sessions.
Read the detailed description
Hyperbaric oxygenation chambers are FDA-approved and regulated devices. Hyperbaric oxygenation therapy (HBOT) is a medical procedure in which participants inspire enriched oxygen while their bodies are subjected to pressure greater than ambient barometric pressure at sea level (i.e., greater than 1 atmosphere absolute, or 760 mmHg). Hyperbaric oxygen therapy elevates tissue oxygen levels, thereby increasing the rate of tissue healing, and enhancing leukocyte-mediated phagocytosis. It may also elevate growth factors, which promotes angiogenesis and healing (Siddiqui, Davidson, \& Mustoe, 1997).
While HBOT is most often used in wound healing and serious infections, it has been utilized in treating various disorders, most notably in cerebral palsy (Liptak, 2005; Marois \& Vanasse, 2003) and other conditions, including fetal alcohol syndrome (Stoller, 2005), brain injury (Rockswold, 1993), and stroke (Helms, 2005) (see Joiner, 2002 for a review). The rationale for using HBOT in participants with neurological and developmental disorders is to relieve hypoxia, which often accompany these conditions. This leads to improvements in microcirculation and relief of cerebral edema by vasoconstriction, therefore leading to decreases in the symptom characteristics.
HBOT is implemented in various dose pressures (ATA) by practitioners for the treatment of symptoms of autism, averaging around 1.3-1.5 atmospheres for one hour sessions, for a minimum of 40 sessions. The results of HBOT are presumed to be long-term, but systematic examination of both short-term and long-term effects is currently warranted.
- Conditions
- Cognition
- Being tested
- Hyperbaric oxygen therapy
- Keywords
- Hyperbaric, Oxygen, 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 oxygen therapyProcedure or surgery
Hyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Healthy Adults Receives: Procedure: Hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CogState touch screen measuring cognitive changes
Measured: Data will be collected according to the following schedule: prior to treatment, following 5, 15, 25, and 40 HBOT treatments, as well as at post-treatment and 1 and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pediatric Partners of Ponte Vedra
- Sponsor type
- University, hospital or other
- Investigators
- Julie Buckley, MD, Principal investigator, President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631215
- Sponsor's protocol ID
- 07.11.0005
- Status last verified
- Jan 2008
- First submitted
- 27 Feb 2008
- Last updated
- 7 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children
- ClinicalTrials.gov ID
- NCT00631215
- Acronym / sponsor ID
- 07.11.0005
- Conditions
- Cognition
- Keywords
- Hyperbaric, Oxygen, autism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pediatric Partners of Ponte VedraUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 7 Mar 2008 (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.
HYPOTHESIS
- Hyperbaric Oxygenation Therapy will be safe to use with neurotypical adults and children.
- Hyperbaric Oxygenation Therapy will have a statistically significant positive effect on measures of cognitive function in neurotypical adults and children.
- The improvement in cognitive function will correlate positively with the number of Hyperbaric Oxygenation Therapy sessions.
- Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up, post 40 treatment sessions.
Detailed description
Hyperbaric oxygenation chambers are FDA-approved and regulated devices. Hyperbaric oxygenation therapy (HBOT) is a medical procedure in which participants inspire enriched oxygen while their bodies are subjected to pressure greater than ambient barometric pressure at sea level (i.e., greater than 1 atmosphere absolute, or 760 mmHg). Hyperbaric oxygen therapy elevates tissue oxygen levels, thereby increasing the rate of tissue healing, and enhancing leukocyte-mediated phagocytosis. It may also elevate growth factors, which promotes angiogenesis and healing (Siddiqui, Davidson, \& Mustoe, 1997).
While HBOT is most often used in wound healing and serious infections, it has been utilized in treating various disorders, most notably in cerebral palsy (Liptak, 2005; Marois \& Vanasse, 2003) and other conditions, including fetal alcohol syndrome (Stoller, 2005), brain injury (Rockswold, 1993), and stroke (Helms, 2005) (see Joiner, 2002 for a review). The rationale for using HBOT in participants with neurological and developmental disorders is to relieve hypoxia, which often accompany these conditions. This leads to improvements in microcirculation and relief of cerebral edema by vasoconstriction, therefore leading to decreases in the symptom characteristics.
HBOT is implemented in various dose pressures (ATA) by practitioners for the treatment of symptoms of autism, averaging around 1.3-1.5 atmospheres for one hour sessions, for a minimum of 40 sessions. The results of HBOT are presumed to be long-term, but systematic examination of both short-term and long-term effects is currently warranted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Hyperbaric oxygen therapyHealthy Adults |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- • Males and females from 6 to 75 years of age with typical cognitive function and no neurologic or psychological diagnoses potentially impairing cognitive function
- Ambulatory or require minimum support walking
- Able to sit still for 12 minutes or longer for the purposes of test administration
- Adequate vision and hearing for the purposes of test administration, per parent
- Able to read and understand basic instructions
Key exclusion criteria (2 listed)
- Current otitis media Sinus infection Asthma Pulmonary cysts Emphysema Upper respiratory infection Severe claustrophobia, intolerance to being in the chamber Unstable/uncontrolled disorder of any kind
- -
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 oxygen therapyHyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes | Procedure or surgery | 1 |
Primary outcome
CogState touch screen measuring cognitive changes
Time frame: Data will be collected according to the following schedule: prior to treatment, following 5, 15, 25, and 40 HBOT treatments, as well as at post-treatment and 1 and 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2008.
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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.
Pediatric Partners of Ponte Vedra
Ponte Vedra Beach, United States
Julie Buckley, MD principal investigator
President
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 therapy in people with Cognition, run by Pediatric Partners of Ponte Vedra 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 14 inclusion and 2 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 7 Mar 2008. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CogState touch screen measuring cognitive changes (time frame: Data will be collected according to the following schedule: prior to treatment, following 5, 15, 25, and 40 HBOT treatments, as well as at post-treatment and 1 and 3-month follow-up). 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 7 Mar 2008.