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 childs 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 ), Childrens 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. Childrens 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
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