The effect of hyperbaric oxygen therapy in autism spectrum disorder
| ISRCTN | ISRCTN71569610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71569610 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/10/2011
- Registration date
- 18/11/2011
- Last edited
- 02/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
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
| Phone | +966 (0)1 467 0848 |
|---|---|
| ayadh2@gmail.com |
Study information
| Study design | Randomized double-blind cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Study the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in Autism Spectrum Disorder (ASD): a randomized double-blind cross-over study |
| Study acronym | HBOT |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2012 |
| Completion date | 01/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 32 |
| Key inclusion criteria | Children with ASD (Autism spectrum disorders) aged between 6 and 12 |
| Key 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 |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 01/01/2014 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
11461
Saudi Arabia
Sponsor information
University/education
King Abdulaziz City for Science and Technology Kingdom of Saudi Arabia
P.O Box 6086
Riyadh
11461
Saudi Arabia
| Website | http://www.kacst.edu.sa |
|---|---|
"ROR" |
https://ror.org/05tdz6m39 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
02/08/2016: Plain English summary added.
