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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Pediatric Partners of Ponte Vedra.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Pediatric Partners of Ponte Vedra
ClinicalTrials.gov Identifier:
NCT00631215
First received: February 27, 2008
Last updated: March 6, 2008
Last verified: January 2008

February 27, 2008
March 6, 2008
January 2008
June 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00631215 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children
Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cognition
Procedure: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes
Experimental: 1
Healthy Adults
Intervention: Procedure: Hyperbaric oxygen therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 2009
June 2009   (final data collection date for primary outcome measure)

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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Both
6 Years to 75 Years
Yes
United States
 
NCT00631215
07.11.0005
No
Julie Buckley, MD, Pediatric Partners of Ponte Vedra
Pediatric Partners of Ponte Vedra
Not Provided
Principal Investigator: Julie Buckley, MD President
Pediatric Partners of Ponte Vedra
January 2008

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