The effect of hyperbaric oxygen therapy in autism spectrum disorder

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71569610

Enrollment

Registered

2011-11-18

Start date

2012-01-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorder Mental and Behavioural Disorders Childhood autism

Interventions

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 b

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
Improvement in communication, social and speech, reflected on academic level	—

Countries

Saudi Arabia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026