Recruiting

Hyperbaric Oxygen Therapy

Sponsor:

Pediatric Partners of Ponte Vedra

Code:

NCT00631215

Conditions

Cognition

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Accepted

Interventions

Hyperbaric oxygen therapy

Study Details

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.

Conditions

Cognition

Study ID

NCT00631215

Start date

Jan, 2008

Status verified date

Jan, 2008

Completion date

Oct, 2009

Anticipated

Primary completion date

Jun, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Accepted

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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Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 1

Healthy Adults

Interventions

Hyperbaric oxygen therapy

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

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 ]

Central Contacts and Locations

Locations

Pediatric Partners of Ponte Vedra

Recruiting

Ponte Vedra Beach, Florida, United States, 32082

Contacts

Laurie Thomas, BA

904-543-1288laurie@pppvonline.com

Principal Investigator:

Julie Buckley, MD

More Information

Sponsor

Pediatric Partners of Ponte Vedra

Last update posted

Mar 7, 2008

Last verified

Jan, 2008

Keywords

  • Hyperbaric
  • Oxygen
  • autism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pediatric Partners of Ponte Vedra on 2008-03-07.