Expired Study
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Ponte Vedra Beach, Florida 32082


Purpose:

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. The improvement in cognitive function will correlate positively with the number of Hyperbaric Oxygenation Therapy sessions. 4. Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up, post 40 treatment sessions.


Study summary:

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.


Criteria:

Inclusion Criteria: - • 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: - 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 Exclusion Criteria: 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 -


Study is Available At:


Original ID:

07.11.0005


NCT ID:

NCT00631215


Secondary ID:


Study Acronym:


Brief Title:

Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children


Official Title:

Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

6 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pediatric Partners of Ponte Vedra


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Julie Buckley, MD
Principal Investigator
President

Study Dates

Start Date:January 2008
Completion Date:October 2009
Completion Type:Anticipated
Primary Completion Date:June 2009
Primary Completion Type:Anticipated
Verification Date:January 2008
Last Changed Date:March 6, 2008
First Received Date:February 27, 2008

Study Outcomes

Outcome Type: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,
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Hyperbaric oxygen therapy
Description:Hyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Healthy Adults

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Pediatric Partners of Ponte Vedra

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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