NCT00631215

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Pediatric Partners of Ponte Vedra · Academic / Other
• Sex: All
• Age: 6 Years – 75 Years
• Healthy volunteers: Accepted

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. 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.

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

Interventions

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

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-06-01
• Completion: 2009-10-01
• First posted: 2008-03-07
• Last updated: 2008-03-07

Locations

1 site across 1 country: United States