Trial Outcomes & Findings for Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism (NCT NCT00584480)

Last Updated: 2012-08-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

10 participants

Primary outcome timeframe

Baseline, 8 Weeks from baseline, and 20 Weeks from baseline

Results posted on

2012-08-07

Participant Flow

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).

Participant milestones

Participant milestones
Measure	Hyperbaric Oxygen Treatment (HBOT) 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.
First 8 Weeks (40 Treatments) STARTED	10
First 8 Weeks (40 Treatments) COMPLETED	10
First 8 Weeks (40 Treatments) NOT COMPLETED	0
4-Week Break From Treatment STARTED	10
4-Week Break From Treatment COMPLETED	10
4-Week Break From Treatment NOT COMPLETED	0
Second 8 Weeks (40 Treatments) STARTED	10
Second 8 Weeks (40 Treatments) COMPLETED	10
Second 8 Weeks (40 Treatments) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hyperbaric Oxygen Treatment (HBOT) n=10 Participants 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.
Age, Categorical <=18 years	10 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	5.3 years STANDARD_DEVIATION 1.8 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline, 8 Weeks from baseline, and 20 Weeks from baseline

Outcome measures

Outcome measures
Measure	Hyperbaric Oxygen Treatment (HBOT) n=10 Participants 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.
Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score CGI-I Score of exactly 1 at 40 days	5 participants
Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score CGI-I Score of exactly 2 at 40 days	5 participants
Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score CGI-I Score of exactly 2 at 80 days	10 participants

Adverse Events

Hyperbaric Oxygen Treatment (HBOT)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Hyperbaric Oxygen Treatment (HBOT) n=10 participants at risk 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.
Nervous system disorders Seizure	10.0% 1/10 • Number of events 1

Other adverse events

Other adverse events
Measure	Hyperbaric Oxygen Treatment (HBOT) n=10 participants at risk 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.
Ear and labyrinth disorders Ear Discomfort	30.0% 3/10 • Number of events 3
Ear and labyrinth disorders Ear Infection	20.0% 2/10 • Number of events 2

Additional Information

Robert L. Hendren, D.O.

UCSF

Phone: 415-476-7198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place