Status:
UNKNOWN
Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children
Lead Sponsor:
Pediatric Partners of Ponte Vedra
Conditions:
Cognition
Eligibility:
All Genders
6-75 years
Phase:
NA
Brief 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 meas...
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 ar...
Eligibility Criteria
Inclusion
- • 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
- 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
- \-
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00631215
Start Date
January 1 2008
End Date
October 1 2009
Last Update
March 7 2008
Active Locations (1)
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1
Pediatric Partners of Ponte Vedra
Ponte Vedra Beach, Florida, United States, 32082