UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043362
Receipt number R000049511
Scientific Title Effect of hyperbaric oxygen therapy and Tomatis sound therapy on children with autism spectrum disorder
Date of disclosure of the study information 2021/02/18
Last modified on 2021/06/14 03:33:42

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Basic information

Public title

Effect of hyperbaric oxygen therapy and Tomatis sound therapy in children with autism spectrum disorder

Acronym

HBOT and Tomatis in autism spectrum disorder

Scientific Title

Effect of hyperbaric oxygen therapy and Tomatis sound therapy on children with autism spectrum disorder

Scientific Title:Acronym

hyperbaric oxygen therapy and Tomatis sound therapy 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 or person

Institute

Assiut University

Institute

Department

Personal name



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 06 Month 14 Day



Link to view the page

Value
https://center6.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