Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism (HBOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00584480
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : April 13, 2012
Last Update Posted : August 7, 2012
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autism
Intervention Other: Hyperbaric Oxygen Treatment (HBOT)
Enrollment 10
Recruitment Details Enrollment took place between October 1, 2007 to April 24, 2009. Children between the ages of 3 and 8 with a diagnosis of Autism Spectrum Disorders (ASD) were recruited from the outpatient autism clinic at the MIND Institute (University of California, Davis).
Pre-assignment Details  
Arm/Group Title Hyperbaric Oxygen Treatment (HBOT)
Hide Arm/Group Description Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
Period Title: First 8 Weeks (40 Treatments)
Started 10
Completed 10
Not Completed 0
Period Title: 4-Week Break From Treatment
Started 10
Completed 10
Not Completed 0
Period Title: Second 8 Weeks (40 Treatments)
Started 10
Completed 10
Not Completed 0
Arm/Group Title Hyperbaric Oxygen Treatment (HBOT)
Hide Arm/Group Description Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
10
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
5.3  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
0
   0.0%
Male
10
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score
Hide Description Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved.
Time Frame Baseline, 8 Weeks from baseline, and 20 Weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hyperbaric Oxygen Treatment (HBOT)
Hide Arm/Group Description:
Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
CGI-I Score of exactly 1 at 40 days 5
CGI-I Score of exactly 2 at 40 days 5
CGI-I Score of exactly 2 at 80 days 10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hyperbaric Oxygen Treatment (HBOT)
Hide Arm/Group Description Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
All-Cause Mortality
Hyperbaric Oxygen Treatment (HBOT)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Hyperbaric Oxygen Treatment (HBOT)
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Nervous system disorders   
Seizure [1]  1/10 (10.00%)  1
[1]
Likely not related to HBOt treatment. Only ear pain, increased fatigue, dehydration, and increased mouthing of objects were judged to be likely related to the HBOT treatment.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hyperbaric Oxygen Treatment (HBOT)
Affected / at Risk (%) # Events
Total   5/10 (50.00%)    
Ear and labyrinth disorders   
Ear Discomfort  3/10 (30.00%)  3
Ear Infection  2/10 (20.00%)  2
1) Small sample size 2) Lack of control group prevented an examination of whether changes in clinical measure of disease severity were due to HBOT or other factors.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert L. Hendren, D.O.
Organization: UCSF
Phone: 415-476-7198
EMail: Robert.Hendren@ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00584480    
Other Study ID Numbers: 200715202-1
First Submitted: December 22, 2007
First Posted: January 2, 2008
Results First Submitted: September 13, 2011
Results First Posted: April 13, 2012
Last Update Posted: August 7, 2012