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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
Sponsor:
Information provided by:
Pediatric Partners of Ponte Vedra

Tracking Information
First Submitted Date  ICMJE February 27, 2008
First Posted Date  ICMJE March 7, 2008
Last Update Posted Date March 7, 2008
Study Start Date  ICMJE January 2008
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children
Official Title  ICMJE Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cognition
Intervention  ICMJE Procedure: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes
Study Arms  ICMJE Experimental: 1
Healthy Adults
Intervention: Procedure: Hyperbaric oxygen therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 6, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00631215
Other Study ID Numbers  ICMJE 07.11.0005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie Buckley, MD, Pediatric Partners of Ponte Vedra
Study Sponsor  ICMJE Pediatric Partners of Ponte Vedra
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie Buckley, MD President
PRS Account Pediatric Partners of Ponte Vedra
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP