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

NCT00631215 | Unknown

• 1 other identifier: 07.11.0005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

HYPOTHESIS

1. 1.Hyperbaric Oxygenation Therapy will be safe to use with neurotypical adults and children.
2. 2.Hyperbaric Oxygenation Therapy will have a statistically significant positive effect on measures of cognitive function in neurotypical adults and children.
3. 3.The improvement in cognitive function will correlate positively with the number of Hyperbaric Oxygenation Therapy sessions.
4. 4.Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up, post 40 treatment sessions.

Conditions

Cognition

Keywords

Hyperbaric; Oxygen; autism

Outcome Measures

Primary Outcomes (1)

• CogState touch screen measuring cognitive changes

  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

Study Arms (1)

1

EXPERIMENTAL

Healthy Adults

Procedure: Hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapy PROCEDURE

Hyperbaric oxygen therapy: 1.3 atmospheres of pressure, 100%0xygen by face mask, for 60 minutes

1

Eligibility Criteria

• Age: 6 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pediatric Partners of Ponte Vedra: lead

Study Sites (1)

Pediatric Partners of Ponte Vedra

Ponte Vedra Beach, Florida, 32082, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Julie Buckley, MD

  President

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 7, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 7, 2008

Record last verified: 2008-01

Locations

US (1)