Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children
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|ClinicalTrials.gov Identifier: NCT00631215|
Recruitment Status : Unknown
Verified January 2008 by Pediatric Partners of Ponte Vedra.
Recruitment status was: Recruiting
First Posted : March 7, 2008
Last Update Posted : March 7, 2008
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Cognition||Procedure: Hyperbaric oxygen therapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||October 2009|
Procedure: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631215
|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 email@example.com|
|Sub-Investigator: Jerry J Kartzinel, MD|
|Principal Investigator: Julie Buckley, MD|
|Principal Investigator:||Julie Buckley, MD||President|