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

Cognition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00631215
• Other study ID #: 07.11.0005
• Status: Recruiting
• Phase: N/A
• First received: February 27, 2008
• Last updated: March 6, 2008
• Start date: January 2008
• Est. completion date: October 2009

Study information

• Verified date: January 2008
• Source: Pediatric Partners of Ponte Vedra
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cognition

Intervention

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

Locations

Country	Name	City	State
United States	Pediatric Partners of Ponte Vedra	Ponte Vedra Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pediatric Partners of Ponte Vedra

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No