Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic

Status Recruiting

Clinical 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. 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.

Clinical Trial 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Cognition

Clinical Trial Details

NCT number	NCT00631215
Study type	Interventional
Source	Pediatric Partners of Ponte Vedra
Contact
Status	Recruiting
Phase	N/A
Start date	January 2008
Completion date	October 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms