Autistic DisorderPhase 1VPHNCT00670891
A Clinical Trial of the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children
A Phase 1 study testing oxygen (Hyperbaric Oxygen Therapy) in people with Autistic Disorder, run by Vachira Phuket Hospital at 1 site in Thailand.
Trial summary
Autism is a developmental and behavioral pattern which includes the triad of impairments, 1. social interaction 2. social communication 3. imagination. Inevitable difficulties in the treatment, managing and handle with autistic children are the main problems. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- oxygen (Hyperbaric Oxygen Therapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2007to Apr 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both sexes
- All aged-group
- All educated group
- Diagnosis - Autistic disorder, Autistic spectrums
- Major symptoms - delayed development, delayed speech
Who cannot join
- Uncontrolled severe explosive behaviours
- Uncontrolled organic or physical symptoms such as seizure, ear infection
- Severe phobic or fearful symptoms
- No parent or caretaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non-Randomized, Open-Label Study on the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children
Autism is a developmental and behavioral pattern which includes the triad of impairments, 1. social interaction 2. social communication 3. imagination. Inevitable difficulties in the treatment, managing and handle with autistic children are the main problems. Their memories are seemingly in picture or photo records, which are difference from normal population. There are many concepts but no concise in causative factors, including useful treatments, useless and prolong remaining in many studies.
HBOT (Hyperbaric Oxygen Therapy) is a quite modern treatment in Thailand for nitrogen imbalance (decompression sickness syndrome or Caisson disease). How can we apply it to treat the autism? A hypothesis shows evidence that neurons surrounding the permanently damaged epicenter of injury can be reactivated with increased oxygen. Oxygen exists in the blood in two forms, combined with hemoglobin and dissolved in plasma. More oxygen is transported by hemoglobin, but oxygen is delivered to the tissues in dissolved form by the liquid portion of blood. HBOT can increase in plasma oxygen to the tissues including the brain. A little change in oxygen can make the better improvements in : cognitive ability, socialization, sleep, calmness, decreased stimming and language. It can make increased in Glutathione (GSH), and Glutathione (GSH) can decreased in oxidative stress with effected to remove metal compounds (mercury) to improve the autism.
This clinical trial study divided into 3 group populations 1. general autism 2. post-treatment chiropractic autism 3. medicated autism. This comparative study shows the major clinical symptoms before and after the treatment with HBOT. This study results and analysis are the most important for our further projects planning.
Read the detailed description
Detailed Description There is a general agreement that early identification of autistic spectrum disorders in children and intervention is extremely important.
We would like to find out beneficial effects for early identification and treatment in the autism. Another meaning, it declares that the autism is treatable and can be prevention in the early stage of the symptoms. According to many studies, they had shown brain injury could be caused by heavy metal effects, chemical poisoning, infection, autoimmune response, poor blood flow, lack of oxygen. There are many alternative therapies that were claimed to have some effects to make better results in autistic symptoms, but no definite one which could absolutely cured to the autism.
HBOT (Hyperbaric Oxygen Therapy) is a new way in the treatment for decompression sickness syndrome (Caisson disease) and it can be applied to intervene or concomitant treatments with some symptoms such as diabetic wounds, burnt wounds.
Vachira Phuket Hospital, HBOT center and child development center was established in 2002. This HBOT center is the only one stand-alone center of provincial hospitals in Thailand. Enthusiastic questions in our proceedings were how to declare our opportunities to be a center in HBOT and child developmental center.
If HBOT can be an effective method in alternative therapies, we can help our numerous autistic children. In our proceeding study we found that HBOT was the least interesting method of alternative therapies for the autism in parental opinions. (Figure 1.)
- General information, the most of sampling groups (75.68%) are female, 40.54% of aged-groups are 30-40 years old, 37.84% of occupations are employee and 32.43% of educations are primary school.
- Information about opinion of alternative therapies, the most of parents think that the music therapy is the best way. The second is Chiropractic and the third is Art therapy but Animal therapy with the pony is the least effective way.
In the topic of the knowledge about Alternative therapies, the most of parents know about Chiropractic, Art therapy and Music therapy as sequence. The parents know Hyperbaric Oxygen Therapy as the least.
They interested in Music therapy, Chiropractic and Art therapy as sequence. But they are interested in animal therapy with pony and dog as the least. The researchers think that the parents' knowledge about each therapy affects their decision making to choose for their children. Vachira Phuket Hospital has Hyperbaric oxygen therapy (Chamber) which is the new therapy for Autistic children but the parents don't have the knowledge about it. So, the researchers wonder how should we give the information to the parents in order to get the most benefit from this therapy.
Figure 1. Autistic parental attitude surveys in effective, knowledge and interesting in various therapies at Vachira Phuket Hospital, July 2007
Whatever it is our opportunities to prove how effective of HBOT in the treatment for autism and represent autistic pathology mechanisms in preceding hypotheses.
Advantages
- Administrator's support is provided.
- Equipment (HBOT) is in the same place with Development Training Clinic.
- Study by professional physicians in various associated experiences and the developmental nurse, psychologist who accustom with children and the parents (caretakers).
- Convenience in transportation, which is in a small province.
- This HBOT is solitary equipment, governed beneath Thailand Ministry of Public Health.
Disadvantages
- Publication in knowledge about HBOT is very low in Thailand.
- Harmful may be unknown hidden.
- Stigmatization is a delicate point in the parents of these children.
- Worrying and guilty feelings are easily occurred in the parents when something may be unexpected happening.
- A small province liked Phuket may be difficult to find volunteers for research or study's enrollment.
- Information gathering and assessment processes including scoring forms may be underneath standardization and not up-to-date.
Problems-solving plans
- Informed knowledge about HBOT, more and more, to the parents and community.
- Pre-treatment evaluation was carefully evaluated according to good clinical practice.
- Respected to their honour, patient's right and kept confidential of the volunteers.
- Reassured the parents and clarified in details of their concerned issues. Explained the strategies explicitly and slowly.
- Therefore studied in a small group, closed observation was applied to integrated in details for descriptive study in the volunteers.
- It could be a pilot study if their any parts of this study were not clearly understood. And thereafter, study planning in the future will be done in the advance conforming design and methodology following our knowledgeable experiences.
- Conditions
- Autistic Disorder
- Being tested
- oxygen (Hyperbaric Oxygen Therapy)
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen (Hyperbaric Oxygen Therapy)Procedure or surgery
Also called HBOT
Current Accepted Applications of HBOT (2008) Jan 2003, ANDI International
- Air or Gas Embolus
- Decompression Illness
- Carbon Monoxide poising
- Clostridial Myonecrosis (Gas Gangrene)
- Necrotizing Fasciitis
- Crush Injury (Compartment syndromes)
- Selected Problem Wounds
- Compromised Skin Flaps or Grafts
- Refractory Osteomyelitis
- Exceptional Anemia due to Blood loss
- Osteoradionecrosis
- Thermal Burns and Radiation Tissue Damage
- Diabetic Wounds
- Intra-Cranial Abscess
- Brain Injury and other Head Trauma
- Cerebral Palsy
- High Altitude Sickness
- Lyme disease
| Study group | Role | What they receive |
|---|---|---|
| HBOT | Experimental | HBOT Receives: Procedure: oxygen (Hyperbaric Oxygen Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental and Skill training assessment, Rajanukul Hospital 5th edition
Measured: 10 sessions assessment
Secondary outcomes (1)
Developmental and Skill training assessment, Rajanukul Hospital 5th edition
Measured: 20 sessions assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vachira Phuket Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jessada Chungpaibulpatana, MD., Principal investigator, Vachira Phuket Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670891
- Sponsor's protocol ID
- VP 000001
- Acronym
- VPH
- Status last verified
- Apr 2008
- First submitted
- 29 Apr 2008
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized, Open-Label Study on the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children
- ClinicalTrials.gov ID
- NCT00670891
- Acronym / sponsor ID
- VPH / VP 000001
- Conditions
- Autistic Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Vachira Phuket HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 2 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism is a developmental and behavioral pattern which includes the triad of impairments, 1. social interaction 2. social communication 3. imagination. Inevitable difficulties in the treatment, managing and handle with autistic children are the main problems. Their memories are seemingly in picture or photo records, which are difference from normal population. There are many concepts but no concise in causative factors, including useful treatments, useless and prolong remaining in many studies.
HBOT (Hyperbaric Oxygen Therapy) is a quite modern treatment in Thailand for nitrogen imbalance (decompression sickness syndrome or Caisson disease). How can we apply it to treat the autism? A hypothesis shows evidence that neurons surrounding the permanently damaged epicenter of injury can be reactivated with increased oxygen. Oxygen exists in the blood in two forms, combined with hemoglobin and dissolved in plasma. More oxygen is transported by hemoglobin, but oxygen is delivered to the tissues in dissolved form by the liquid portion of blood. HBOT can increase in plasma oxygen to the tissues including the brain. A little change in oxygen can make the better improvements in : cognitive ability, socialization, sleep, calmness, decreased stimming and language. It can make increased in Glutathione (GSH), and Glutathione (GSH) can decreased in oxidative stress with effected to remove metal compounds (mercury) to improve the autism.
This clinical trial study divided into 3 group populations 1. general autism 2. post-treatment chiropractic autism 3. medicated autism. This comparative study shows the major clinical symptoms before and after the treatment with HBOT. This study results and analysis are the most important for our further projects planning.
Detailed description
Detailed Description There is a general agreement that early identification of autistic spectrum disorders in children and intervention is extremely important.
We would like to find out beneficial effects for early identification and treatment in the autism. Another meaning, it declares that the autism is treatable and can be prevention in the early stage of the symptoms. According to many studies, they had shown brain injury could be caused by heavy metal effects, chemical poisoning, infection, autoimmune response, poor blood flow, lack of oxygen. There are many alternative therapies that were claimed to have some effects to make better results in autistic symptoms, but no definite one which could absolutely cured to the autism.
HBOT (Hyperbaric Oxygen Therapy) is a new way in the treatment for decompression sickness syndrome (Caisson disease) and it can be applied to intervene or concomitant treatments with some symptoms such as diabetic wounds, burnt wounds.
Vachira Phuket Hospital, HBOT center and child development center was established in 2002. This HBOT center is the only one stand-alone center of provincial hospitals in Thailand. Enthusiastic questions in our proceedings were how to declare our opportunities to be a center in HBOT and child developmental center.
If HBOT can be an effective method in alternative therapies, we can help our numerous autistic children. In our proceeding study we found that HBOT was the least interesting method of alternative therapies for the autism in parental opinions. (Figure 1.)
- General information, the most of sampling groups (75.68%) are female, 40.54% of aged-groups are 30-40 years old, 37.84% of occupations are employee and 32.43% of educations are primary school.
- Information about opinion of alternative therapies, the most of parents think that the music therapy is the best way. The second is Chiropractic and the third is Art therapy but Animal therapy with the pony is the least effective way.
In the topic of the knowledge about Alternative therapies, the most of parents know about Chiropractic, Art therapy and Music therapy as sequence. The parents know Hyperbaric Oxygen Therapy as the least.
They interested in Music therapy, Chiropractic and Art therapy as sequence. But they are interested in animal therapy with pony and dog as the least. The researchers think that the parents' knowledge about each therapy affects their decision making to choose for their children. Vachira Phuket Hospital has Hyperbaric oxygen therapy (Chamber) which is the new therapy for Autistic children but the parents don't have the knowledge about it. So, the researchers wonder how should we give the information to the parents in order to get the most benefit from this therapy.
Figure 1. Autistic parental attitude surveys in effective, knowledge and interesting in various therapies at Vachira Phuket Hospital, July 2007
Whatever it is our opportunities to prove how effective of HBOT in the treatment for autism and represent autistic pathology mechanisms in preceding hypotheses.
Advantages
- Administrator's support is provided.
- Equipment (HBOT) is in the same place with Development Training Clinic.
- Study by professional physicians in various associated experiences and the developmental nurse, psychologist who accustom with children and the parents (caretakers).
- Convenience in transportation, which is in a small province.
- This HBOT is solitary equipment, governed beneath Thailand Ministry of Public Health.
Disadvantages
- Publication in knowledge about HBOT is very low in Thailand.
- Harmful may be unknown hidden.
- Stigmatization is a delicate point in the parents of these children.
- Worrying and guilty feelings are easily occurred in the parents when something may be unexpected happening.
- A small province liked Phuket may be difficult to find volunteers for research or study's enrollment.
- Information gathering and assessment processes including scoring forms may be underneath standardization and not up-to-date.
Problems-solving plans
- Informed knowledge about HBOT, more and more, to the parents and community.
- Pre-treatment evaluation was carefully evaluated according to good clinical practice.
- Respected to their honour, patient's right and kept confidential of the volunteers.
- Reassured the parents and clarified in details of their concerned issues. Explained the strategies explicitly and slowly.
- Therefore studied in a small group, closed observation was applied to integrated in details for descriptive study in the volunteers.
- It could be a pilot study if their any parts of this study were not clearly understood. And thereafter, study planning in the future will be done in the advance conforming design and methodology following our knowledgeable experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBOT | Experimental | Procedure: oxygen (Hyperbaric Oxygen Therapy)HBOT |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Both sexes
- All aged-group
- All educated group
- Diagnosis - Autistic disorder, Autistic spectrums
- Major symptoms - delayed development, delayed speech
Key exclusion criteria (4 listed)
- Uncontrolled severe explosive behaviours
- Uncontrolled organic or physical symptoms such as seizure, ear infection
- Severe phobic or fearful symptoms
- No parent or caretaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen (Hyperbaric Oxygen Therapy)Also: HBOTCurrent Accepted Applications of HBOT (2008) Jan 2003, ANDI International 1. Air or Gas Embolus 2. Decompression Illness 3. Carbon Monoxide poising 4. Clostridial Myonecrosis (Gas Gangrene) 5. Necrotizing Fasciitis 6. Crush Injury (Compartment syndromes) 7. Selected Problem Wounds 8. Compromised Skin Flaps or Grafts 9. Refractory Osteomyelitis 10. Exceptional Anemia due to Blood loss 11. Osteoradionecrosis 12. Thermal Burns and Radiation Tissue Damage 13. Diabetic Wounds 14. Intra-Cranial Abscess 15. Brain Injury and other Head Trauma 16. Cerebral Palsy 17. High Altitude Sickness 18. Lyme disease | Procedure or surgery | HBOT |
Primary outcome
Developmental and Skill training assessment, Rajanukul Hospital 5th edition
Time frame: 10 sessions assessment
1 secondary outcome
Developmental and Skill training assessment, Rajanukul Hospital 5th edition
Time frame: 20 sessions assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessada Chungpaibulpatana, MD. principal investigator
Vachira Phuket Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oxygen (Hyperbaric Oxygen Therapy) in people with Autistic Disorder, run by Vachira Phuket Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental and Skill training assessment, Rajanukul Hospital 5th edition (time frame: 10 sessions assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2008.