UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043362
Receipt No. R000049511
Scientific Title Effect of hyperbaric oxygen therapy and auditory integration training on children with autism spectrum disorder
Date of disclosure of the study information 2021/02/18
Last modified on 2021/02/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of hyperbaric oxygen therapy and auditory integration training on children with autism spectrum disorder
Acronym hyperbaric oxygen therapy and auditory integration training for ASD
Scientific Title Effect of hyperbaric oxygen therapy and auditory integration training on children with autism spectrum disorder
Scientific Title:Acronym hyperbaric oxygen therapy and auditory integration training for ASD
Region
Africa

Condition
Condition autism spectrum disorder (ASD)
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This work aimed to study the effect of HBOT and AIT either separately or together in autistic Egyptian children, the best schedule, the patient's age when starting treatment, the duration of illness, the sex of the patients, and the effect of combination therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ASD core manifestation improvement
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Hyperbaric oxygen therapy -Group A (n= 34)


Interventions/Control_2 Auditory integration therapy-Group B (n=38)
Interventions/Control_3 Combined therapy (HBOT plus AIT)- Group C (n= 49)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
2 years-old <=
Age-upper limit
18 years-old >
Gender Male and Female
Key inclusion criteria Autism patient under 18 years of age
Key exclusion criteria DSM-V diagnosis of any Pervasive Developmental Disorder other than ASD, chronic ear infections or problems, or current sinus infections, uncontrolled bronchial asthma, uncontrolled convulsion, currently undergoing other therapies
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Khaled
Middle name
Last name Saad
Organization Assiut University
Division name Pediatric department
Zip code 71516
Address Assiut University 71516, Asyut Egypt
TEL +20882368373
Email khaled.ali@med.au.edu.eg

Public contact
Name of contact person
1st name Mohamed
Middle name
Last name Eltellawy
Organization Assiut University
Division name Pediatric department
Zip code 71516
Address Asyut Egypt
TEL +20882368373
Homepage URL
Email Eltellawy270@hotmail.com

Sponsor
Institute Assiut University
Institute
Department

Funding Source
Organization Assiut University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Assiut University
Address Assiut University, Egypt
Tel +20882368371
Email ahmed.khalifa@med.au.edu.eg

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Assiut University, Egypt

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 18 Day

Related information
URL releasing protocol The study included 121 autistic children (3 to 18 yrs
Publication of results Unpublished

Result
URL related to results and publications The study included 121 autistic children (3 to 18 yrs
Number of participants that the trial has enrolled 121
Results Patients treated with combined therapy showed significantly lower CARS after therapy than in patients treated with either HBOT or AIT alone.
Results date posted
2021 Year 02 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The study included 121 autistic children (3 to 18 yrs
Participant flow The study included 121 autistic children (3 to 18 yrs
Adverse events No Adverse events
Outcome measures The study included 121 autistic children (3 to 18 yrs) treated with HBOT (group A), AIT (group B), or together (group C). Childhood autism rating scale (CARS) was done before and after the treatment schedule. CARS after either HBOT or AIT separately or in combination were significantly lower than before. Also, CARS after all types of therapy showed significant improvement in relation to the patient age (less than six years), the duration of illness (less than one year), the schedule of therapy (every other day), and the patient's sex (female). Patients treated with combined therapy showed significantly lower CARS after therapy than in patients treated with either HBOT or AIT alone.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
2017 Year 01 Month 05 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2019 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 02 Month 18 Day
Last modified on
2021 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049511

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.