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| Sponsor: | Pediatric Partners of Ponte Vedra |
|---|---|
| Information provided by: | Pediatric Partners of Ponte Vedra |
| ClinicalTrials.gov Identifier: | NCT00631215 |
Purpose
HYPOTHESIS
| Condition | Intervention |
|---|---|
|
Cognition |
Procedure: Hyperbaric oxygen therapy |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Healthy Adults
|
Procedure: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes
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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.
Eligibility| Ages Eligible for Study: | 6 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
In addition, the participant must be:
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
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Contacts and Locations| United States, Florida | |
| Pediatric Partners of Ponte Vedra | Recruiting |
| Ponte Vedra Beach, Florida, United States, 32082 | |
| Contact: Laurie Thomas, BA 904-543-1288 ext 10 laurie@pppvonline.com | |
| Sub-Investigator: Jerry J Kartzinel, MD | |
| Principal Investigator: Julie Buckley, MD | |
| Principal Investigator: | Julie Buckley, MD | President |
More Information
| Responsible Party: | Julie Buckley, MD, Pediatric Partners of Ponte Vedra |
| ClinicalTrials.gov Identifier: | NCT00631215 History of Changes |
| Other Study ID Numbers: | 07.11.0005 |
| Study First Received: | February 27, 2008 |
| Last Updated: | March 6, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Hyperbaric Oxygen autism |