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
  Purpose

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.

Condition Intervention
Cognition
Procedure: Hyperbaric oxygen therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Hyperbaric Oxygen Therapy on Cognitive Function on Autistic Spectrum Disordered Children

Resource links provided by NLM:


Further study details as provided by Pediatric Partners of Ponte Vedra:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Healthy Adults
Procedure: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes

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.

  Eligibility

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631215

Locations
United States, Florida
Pediatric Partners of Ponte Vedra Recruiting
Ponte Vedra Beach, Florida, United States, 32082
Contact: Laurie Thomas, BA    904-543-1288 ext 10    laurie@pppvonline.com   
Sub-Investigator: Jerry J Kartzinel, MD         
Principal Investigator: Julie Buckley, MD         
Sponsors and Collaborators
Pediatric Partners of Ponte Vedra
Investigators
Principal Investigator: Julie Buckley, MD President
  More Information

No publications provided

Responsible Party: Julie Buckley, MD, Pediatric Partners of Ponte Vedra
ClinicalTrials.gov Identifier: NCT00631215     History of Changes
Other Study ID Numbers: 07.11.0005
Study First Received: February 27, 2008
Last Updated: March 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Pediatric Partners of Ponte Vedra:
Hyperbaric
Oxygen
autism

ClinicalTrials.gov processed this record on April 23, 2014