The Listening Program® with bone conduction headphones for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Childrens's Health Specialty Center Richardson, Richardson, TX
Autism Spectrum Disorder+1 More
The Listening Program® with bone conduction headphones - Device
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

The Listening Program® With Bone Conduction Headphones Changes Hypersensitivity to Sound and Behavioral Responses

See full description

Eligible Conditions

  • Autism Spectrum Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Autism Spectrum Disorder

Study Objectives

This trial is evaluating whether The Listening Program® with bone conduction headphones will improve 2 primary outcomes, 1 secondary outcome, and 2 other outcomes in patients with Autism Spectrum Disorder. Measurement will happen over the course of To be administered at baseline, 1-week following a 40-week use of the listening program..

Month 3
Change from 41 Weeks (Immediately Post-Treatment) Adaptive Behavior Assessment, Third Edition (ABAS-3) Score After 3 months of No Treatment
To be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment
Autism Treatment Evaluation Checklist (ATEC)
Pediatric Evaluation of Disability Inventory Computer Adaptive Test with ASD Scales (PEDI-CAT (ASD))
Sensory Processing Measure™ (SPM™)
To be administered at baseline, 1-week following a 40-week use of the listening program.
Change from Baseline Adaptive Behavior Assessment System, Third Edition (ABAS-3) Score at 41 Weeks (Immediately Post-Treatment)

Trial Safety

Safety Progress

1 of 3

Other trials for Autism Spectrum Disorder

Trial Design

1 Treatment Group

The Listening Program® with bone conduction headphones
1 of 1
Experimental Treatment

This trial requires 8 total participants across 1 different treatment group

This trial involves a single treatment. The Listening Program® With Bone Conduction Headphones is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

The Listening Program® with bone conduction headphones
Device
The Listening Program ® Spectrum music requires a person listen to psycho-acoustically modified classical music online using specialized "Waves" ™ headphones. The headphones transmit sound through bone conduction which provides another mode of perceiving sound (https://advancedbrain.com). The Listening Program ® can be carried out in the home environment with either the base schedule, two fifteen minute sessions at least 30 minutes apart, or a condensed schedule for 30 minutes. Bone conduction allows the listening experience to go deeper into the vestibular system which is purported to reduce stress, help regulate the "fight or flight" response, and allow the listener to achieve a state of calm and relaxed alertness. This theory is based on the function of the vagus nerve, the 10th cranial nerve, which has branches that extend to the eardrum. Stimulation of the vagus nerve stimulates the parasympathetic nervous system (Allen, 2008).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: to be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly to be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment for reporting.

Who is running the study

Principal Investigator
S. V.
Suzanne Vercontaire, Occupational Therapist III
Children's Health

Closest Location

Childrens's Health Specialty Center Richardson - Richardson, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Between the ages of 5 and 10 years old
Diagnosis of autism spectrum disorder
Auditory SOR defined by "Some Problems or Definite Dysfunction" on the Hearing section on the Sensory Processing Measure Home Form.
Caregiver must be available to supervise listening sessions at home
English Speaking

Patient Q&A Section

What are common treatments for autism spectrum disorder?

"Aspects of ASD are treated through several interventions, including pharmacotherapy and behavioral approaches. Early intervention and evidence-based treatment strategies are necessary to maximize the impact of intervention and minimize comorbidities." - Anonymous Online Contributor

Unverified Answer

Can autism spectrum disorder be cured?

"There are many uncertainties regarding the effectiveness of intervention programs in the treatment of ASDs, and many of the issues are unresolved. Further research would improve our understanding of ASDs and its natural history, and provide more evidence for and against the theoretical models." - Anonymous Online Contributor

Unverified Answer

How many people get autism spectrum disorder a year in the United States?

"According to the U.S. Centers for Disease Control, the prevalence of autism spectrum disorder is estimated to be around one in 1,200 of the US population. In 2001, there were an estimated 40 to 41 million people with autism, making it the most common single reason for institutionalization of persons with autism in U.S. care. Estimates were that 1 in 50 children of autistic adults will be diagnosed as autistic, making autism spectrum disorder the most common genetic cause of autism. A recent study found that as much as one in four autistic individuals are not the result of genetic disorders. Instead, they were found to be the result of an environmental insult and a rare mutation in chromosomes." - Anonymous Online Contributor

Unverified Answer

What is autism spectrum disorder?

"The term ASD is commonly employed despite its heterogeneous nature; while we use the term “autism spectrum” to describe one of the many subtypes, “ ASD” may also include other clinical and diagnostic subtypes. Furthermore, we are well aware that the term ASD denotes only a symptom cluster and not a disease state. Therefore, the label ASD or ASD symptoms is not intended as a diagnostic term." - Anonymous Online Contributor

Unverified Answer

What are the signs of autism spectrum disorder?

"The absence of social skills and speech or language difficulties are two of the key challenges in diagnosing ASD, although other key challenges can be identified including limited eye contact, poor eye to hand coordination, limited eye movement and delayed developmental milestones. For individuals who are able to communicate their needs, it is important to get them to describe their experiences of symptoms so a clearer picture of their experiences can be obtained. Some people are extremely cautious and quiet, but most cases of ASD can be detected when all other possible causes of the symptoms are excluded. The most effective method of diagnosing ASD is to follow the autism spectrum spectrum model with two or more informants." - Anonymous Online Contributor

Unverified Answer

What causes autism spectrum disorder?

"There is no single cause for ASD. A variety of contributing and environmental factors are required to develop the condition. These factors include genetic predisposition, adverse experiences during critical periods of brain development, genetic or epigenetic susceptibility, and environmental factors such as pollutants and toxins." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets autism spectrum disorder?

"Results from a recent paper suggests that 1 out of every 20 children under 4 years will also have autism spectrum disorder. The average age the children with ASD were diagnosed is 8.5 years old. But these numbers might not be perfectly accurate since many of the cases were under-diagnosed. A number of different types were present in autistic children that showed a high incidence of symptoms for ASD. Autism is associated with genetic causes, but it can occur by environmental influences as well. So, more research needs to be done in order to ascertain the causes of ASD. But in general, it is clear that ASD will be diagnosed in children of all ethnicities and ages." - Anonymous Online Contributor

Unverified Answer

Does the listening program® with bone conduction headphones improve quality of life for those with autism spectrum disorder?

"For those with ASD using an automated listening program with bone conduction headphones, hearing ability has improved over a 6-month period and the patients reported a significant improvement in quality of life and satisfaction. The magnitude of these improvements is larger than those reported by traditional audiologists when using standard bone conduction headphones." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of the listening program® with bone conduction headphones?

"Findings from a recent study suggest the listening program® with bone conduction headphones is able to improve speech perception performance, a prerequisite for optimizing communication potential." - Anonymous Online Contributor

Unverified Answer

How serious can autism spectrum disorder be?

"Children with ASD are more likely than children without ASD to have a serious health state (e.g., IBD, pneumonia, or anemia); these are not necessarily comorbid condition(s) of ASD itself." - Anonymous Online Contributor

Unverified Answer

How does the listening program® with bone conduction headphones work?

"The use of bone conduction headphones may result in improved speech quality in children and youths with ASD, especially those with higher and softer-to-the-ear hearing thresholds." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating autism spectrum disorder?

"There has been no major breakthrough in autism treatment. However, there are suggestions that autism may be treatable with the use of non-pharmacological strategies in combination with the use of medications. The benefits of a multidomain approach on autism treatment should be tested in a large controlled study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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