Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children
Primary Purpose
Cognition
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric oxygen therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Cognition focused on measuring Hyperbaric, Oxygen, autism
Eligibility Criteria
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)
- 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 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
-
Sites / Locations
- Pediatric Partners of Ponte VedraRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Healthy Adults
Outcomes
Primary Outcome Measures
CogState touch screen measuring cognitive changes
Secondary Outcome Measures
Full Information
NCT ID
NCT00631215
First Posted
February 27, 2008
Last Updated
March 6, 2008
Sponsor
Pediatric Partners of Ponte Vedra
1. Study Identification
Unique Protocol Identification Number
NCT00631215
Brief Title
Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children
Official Title
Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Pediatric Partners of Ponte Vedra
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
HYPOTHESIS
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition
Keywords
Hyperbaric, Oxygen, autism
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Healthy Adults
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric oxygen therapy
Intervention Description
Hyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
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 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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Buckley, MD
Organizational Affiliation
President
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Partners of Ponte Vedra
City
Ponte Vedra Beach
State/Province
Florida
ZIP/Postal Code
32082
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie Thomas, BA
Phone
904-543-1288
Ext
10
Email
laurie@pppvonline.com
First Name & Middle Initial & Last Name & Degree
Jerry J Kartzinel, MD
First Name & Middle Initial & Last Name & Degree
Julie Buckley, MD
12. IPD Sharing Statement
Learn more about this trial
Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children
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