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Effects of Hyperbaric Oxygen Therapy on Children With Autism

NCT00406159 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-08-07

No results posted yet for this study

Summary

PURPOSE

The purpose of this investigation is to evaluate the cognitive and behavioral effects of Hyperbaric Oxygenation Therapy in children who present with a diagnosis of autism spectrum disorder.

HYPOTHESIS

1. Hyperbaric Oxygenation Therapy will be safe to use with children with autism.
2. Hyperbaric Oxygenation Therapy will have a statistically significant effect on the symptoms of autism.
3. Hyperbaric Oxygenation Therapy will have a clinically significant observable effect on the overt symptoms of autism.
4. The decreases in the symptoms of autism will correlate positively with the number of Hyperbaric Oxygenation Therapy sessions.
5. Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up, post 40 treatment sessions.

SPECIFIC AIMS

1. Provide further evidence for the safety of Hyperbaric Oxygenation Therapy in children with autism.
2. To quantitatively assess the effects of Hyperbaric Oxygenation Therapy on behavioral and cognitive symptoms of autism before, during, and after treatment.
3. Identify number of treatments required to reach therapeutic effects.
4. Identify the length and durability of treatment effect and maintenance.

Conditions

Interventions

DEVICE

Hyperbaric Oxygen Therapy

Sponsors & Collaborators

  • Thoughtful House

    lead OTHER

Principal Investigators

  • Andrew Wakefield, MD · Thoughtful House Center for Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Completion
2007-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00406159 on ClinicalTrials.gov