Condition category
Mental and Behavioural Disorders
Date applied
09/10/2011
Date assigned
18/11/2011
Last edited
02/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Autism Spectrum Disorder (ASD) is a condition where the main features are impairments in social interaction, difficulty with communication, and restrictive and repetitive behaviors. Hyperbaric oxygen therapy involves inhaling up to 100% oxygen at a pressure greater than one atmosphere (atm) in a pressurized chamber. The aim of this study is to test the effectiveness of hyperbaric oxygen therapy on the symptoms of ASD.

Who can participate?
Children aged 3-18 with Autism Spectrum Disorder (ASD)

What does the study involve?
Participating children are re-diagnosed by a qualified psychologist and aspects of their behavior and IQ are tested. Participants provide blood samples and undergo a scan before the start of the treatment. Participants are randomly allocated into two groups. One group follows a gluten and casein free diet supervised by a dietician for 4 months before the hyperbaric oxygen sessions. The other group receives no dietary preparation. All participants have 40 1-hour sessions of hyperbaric oxygen therapy at 2 ATA pressure at a rate of once a day for 8 weeks. There are no treatments or tests for 4 weeks after that, then participants have another 40 1-hour sessions at 1 ATA pressure at a rate of once a day for 8 weeks. There are no treatments or tests for 4 weeks after that.

What are the possible benefits and risks of participating?
The possible benefits are improvements in ASD symptoms and signs, which we are testing in our study. Participants may experience confinement anxiety and ear discomfort.

Where is the study run from?
King Saud University (Saudi Arabia)

When is the study starting and how long is it expected to run for?
January 2012 to January 2014

Who is funding the study?
King Abdulaziz City for Science and Technology (Saudi Arabia)

Who is the main contact?
Prof. Laila Y. AL-ayadhi
ayadh2@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Laila AL-Ayadhi

ORCID ID

Contact details

Director of KSU-Autism Research and Treatment center (99)
Supervisor of Shaik AL-Amodi Autism Research Chair
Department of physiology (29)
Faculty of Medicine
King Saud University
PO Box 2925
Riyadh
11461
Saudi Arabia
+966 (0)1 467 0848
ayadh2@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Study the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in Autism Spectrum Disorder (ASD): a randomized double-blind cross-over study

Acronym

HBOT

Study hypothesis

1. To determine the efficacy of HBOT on symptoms of ASD
2. To determine the effects of HBOT on oxidative stress markers, inflammatory biomarkers and immunological biomarkers in autistic children

Ethics approval

Not provided at time of registration

Study design

Randomized double-blind cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Autism spectrum disorder

Intervention

1. This project will be conducted on 32 ASD children between 6 and 12 years of age
2. Written informed consent will be obtained from each child’s parent(s) prior to starting HBOT.
3. Each child will be re-diagnosed by a qualified psychologist using Autism Diagnostic Observation Schedule (ADOS), Childhood Autism Rating Scale (CARS 2) and the several aspects of their behavior and IQ for each candidate will be tested using Social Responsiveness Scale (SRS ), Children’s Communication Checklist (CCC) and Aberrant Behavior Checklist– Community (ABC-C), Stanford Binet Intelligence Scale
4. All ASD candidates with one of their parent will be screened according to HBOT criteria by
4.1. ENT specialist
4.2. Pediatrician
4.3. HBOT specialist
5. Blood samples of each candidate will be taken for testing of oxidative stress, inflammatory and immunological biomarkers
6. Single Photon Emission Computed Tomography (SECT) for ASD candidates before the session of HBOT and at the end of the project
7. ASD candidates will be divided into the following groups:
7.1. Group 1 No dietary preparation prior to HBOT session
7.2. Group 2 Dietary preparation ( gluten & casein free diet supervised by a Dietician for four months prior to HBOT session
8. All candidates will have 40 sessions for 1 hour of HBOT at 1 or 2 atmospheres absolute (ATA) and 100% oxygen (after adjustment for the pressure effect) every day over a 4-5 months period

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

1. Behavioral psychological parameters measure
1.1. Autism Diagnostic Observation Schedule (ADOS)
1.2. Childhood Autism Rating Scale (CARS 2)
2. The several aspects of their behavior and IQ for each candidate will be tested using
2.1. Social Responsiveness Scale (SRS )
2.2. Children’s Communication Checklist (CCC)
2.3. Aberrant Behavior Checklist– Community (ABC-C)
2.4. Stanford Binet Intelligence Scale
2.5. Oxidative stress biomarkers (superoxide dismutase, gluthathione peroxidase, vit E, vit C)
2.6. Inflammatory biomarkers (IL-2, IL-7, IL-10)
2.7. Immunological biomarkers (IgG, IgA, anti-Myelin basic protein IgG, anti-ribosomal IgG , anti-ganglioside IgG)

Secondary outcome measures

Improvement in communication, social and speech, reflected on academic level

Overall trial start date

01/01/2012

Overall trial end date

01/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Children with ASD (Autism spectrum disorders) aged between 6 and 12

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

32

Participant exclusion criteria

The following are the contraindications for the use of HBOT:
1. Pneumothorax
2. Previous chest surgery
3. Any lung disease
4. Viral infections
5. Recent (within the previous 2 months) middle ear surgery
6. Optic neuritis
7. Seizure disorders
8. Congenital spherocytosis
9. Psychiatric problems, especially claustrophobia
10. Recent dental procedures
11. Deafness or ringing noises in ears
12. Severe or frequent headaches
13. Migraine
14. Fainting or blackouts
15. Convulsions, fits or epilepsy
16. Concussion or head injury
17. Heart diseases
18. Pregnancy

Recruitment start date

01/01/2012

Recruitment end date

01/01/2014

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

King Saud University
Riyadh
11461
Saudi Arabia

Sponsor information

Organisation

King Abdulaziz City for Science and Technology (Saudi Arabia)

Sponsor details

King Abdulaziz City for Science and Technology Kingdom of Saudi Arabia
P.O Box 6086
Riyadh
11461
Saudi Arabia

Sponsor type

University/education

Website

http://www.kacst.edu.sa

Funders

Funder type

University/education

Funder name

King Abdul Aziz City for Science and Technology, King Saud University (Saudi Arabia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/08/2016: Plain English summary added.