The effect of hyperbaric oxygen therapy in autism spectrum disorder
Phase 3
Completed
- Conditions
- Autism spectrum disorderMental and Behavioural DisordersChildhood autism
- Registration Number
- ISRCTN71569610
- Lead Sponsor
- King Abdulaziz City for Science and Technology (Saudi Arabia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Children with ASD (Autism spectrum disorders) aged between 6 and 12
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Behavioral psychological parameters measure<br>1.1. Autism Diagnostic Observation Schedule (ADOS)<br>1.2. Childhood Autism Rating Scale (CARS 2) <br>2. The several aspects of their behavior and IQ for each candidate will be tested using <br>2.1. Social Responsiveness Scale (SRS )<br>2.2. Children?s Communication Checklist (CCC) <br>2.3. Aberrant Behavior Checklist? Community (ABC-C)<br>2.4. Stanford Binet Intelligence Scale<br>2.5. Oxidative stress biomarkers (superoxide dismutase, gluthathione peroxidase, vit E, vit C)<br>2.6. Inflammatory biomarkers (IL-2, IL-7, IL-10) <br>2.7. Immunological biomarkers (IgG, IgA, anti-Myelin basic protein IgG, anti-ribosomal IgG , anti-ganglioside IgG)
- Secondary Outcome Measures
Name Time Method Improvement in communication, social and speech, reflected on academic level