The Listening Program for Autism

Overseen By Caitlin Deville, MPT,DSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Health

Disqualifiers: Seizure disorder, Hearing impairments, Cerebral palsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a sound-based treatment called The Listening Program® using bone conduction headphones to assist children with Autism Spectrum Disorder who experience auditory sensory over- and under-responsivity (SOR). The treatment involves listening to specially modified classical music through bone conduction headphones, which send sound directly to the inner ear and may help reduce stress and improve life skills. This approach aims to create a calming effect and enhance how children respond to sounds in their environment. It suits children aged 5-10 with autism and sound sensitivity issues, provided their caregivers can supervise sessions at home. As an unphased trial, this study offers a unique opportunity for children to potentially benefit from an innovative treatment approach.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that The Listening Program® with bone conduction headphones is safe for children with ASD?

Research has shown that The Listening Program® using bone conduction headphones has been studied in children with sound sensitivities, including those with Autism Spectrum Disorder (ASD). These studies have evaluated its effectiveness in reducing sound sensitivity and improving social behavior in children with ASD.

Bone conduction headphones send sound directly to the inner ear through the bones of the skull, bypassing the outer and middle ear. This method is believed to deliver sound more effectively and may help reduce stress and calm the nervous system. The aim is to lower the "fight or flight" response, helping children feel relaxed yet alert.

While detailed safety data from these studies aren't specifically mentioned, bone conduction technology is generally considered safe and is already used in various therapies. The Listening Program® has been available since 2012 and is used at home, suggesting it is well-tolerated. No major negative effects were reported in the studies reviewed, indicating that the treatment is likely safe for children with ASD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about The Listening Program® with bone conduction headphones for autism because it offers a unique approach to managing symptoms. Unlike traditional therapies that often focus on behavioral interventions or medication, this program uses psycho-acoustically modified music delivered through bone conduction headphones. This method is designed to stimulate the vagus nerve, potentially enhancing the parasympathetic nervous system's response, which might help reduce stress and promote a calm, alert state. The added convenience of using this program at home makes it an appealing option for families seeking flexible treatment solutions.

What evidence suggests that The Listening Program® with bone conduction headphones might be an effective treatment for auditory SOR in children with ASD?

Research has shown that The Listening Program® with bone conduction headphones, which participants in this trial will use, can help children with autism by addressing sound processing issues. Studies have found that this sound-based method significantly improves life skills and behavior in these children. The program uses low-frequency music to stimulate a nerve that calms the body, reducing stress and managing the natural "fight-or-flight" response, leading to a calmer state. It also helps with sound sensitivity by improving ear muscle function, making it easier to handle different noises. Overall, this approach offers a promising way to manage sound sensitivity in children with autism. ^{1 3 6 7 8}

Who Is on the Research Team?

Suzanne Vercontaire

Principal Investigator

Children's Health

Are You a Good Fit for This Trial?

This trial is for children aged 5-10 with Autism Spectrum Disorder who have issues with sound sensitivity. They must speak English and have a caregiver to supervise home listening sessions. It's not suitable for kids with cerebral palsy, seizure disorders, hearing impairments, previous listening therapy, or certain genetic diseases.

Inclusion Criteria

My child is between 5 and 10 years old.

I have someone to help me with my treatment sessions at home.

I have been diagnosed with autism spectrum disorder.

Exclusion Criteria

Non-English speakers

Cerebral palsy

I have been diagnosed with a seizure disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Demographic information collected and baseline assessments conducted

1 week

1 visit (in-person)

Intervention

Participants receive The Listening Program at home for 40 weeks

40 weeks

3 virtual check-ins at 10-week intervals

Post-Intervention

Post-treatment assessments conducted 1 week after intervention

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in adaptive behavior and sensory processing 3 months after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• The Listening Program® with bone conduction headphones

Trial Overview The study tests The Listening Program® using bone conduction headphones to see if it helps children with ASD who are overly sensitive to sounds improve their behavior and daily skills. The program uses low-frequency music over a recommended period of 40 weeks.

How Is the Trial Designed?

Group I: The Listening Program® with bone conduction headphones Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Children's Health

Lead Sponsor

Trials

8

Recruited

460+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10982311/

Improvement of symptoms in children with autism by ... In the cross-sectional study, the experimental group showed significant improvement in symptoms after TOMATIS training compared to the control ...

2. ctv.veeva.com ctv.veeva.com/study/the-listening-program-r-with-bone-conduction-headphones-changes-hypersensitivity-to-sound-and-behavio

The Listening Program® With Bone Conduction Headphones ... The objective of this study is to investigate changes in adaptive life skills and behavioral responses in children with ASD using Advanced Brain ...

3. scholarlycollection.childrens.com scholarlycollection.childrens.com/cgi/viewcontent.cgi?article=1024&context=nursing-anf2023

Sound-based Intervention for Children with Autism ... Advanced Brain Technologies' The Listening Program (TLP)® Spectrum music with. Waves™ (bone conduction) headphones is a 40-week sound-based intervention.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4117928/

Reducing Auditory Hypersensitivities in Autistic Spectrum ... LPP was hypothesized to reduce auditory hypersensitivities by increasing the neural tone to the middle ear muscles to functionally dampen competing sounds.

5. advancedbrain.com advancedbrain.com/about-tlp/

About The Listening Program The Listening Program (TLP) uses neuroscience-based music as a therapy to overcome negative sound exposure and achieve optimum brain health and functioning.

6. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-8-2021-95b9a

The Listening Program for Autism · Info for Participants This trial is testing a special music program using special headphones for children aged 5-10 with autism who are sensitive to sounds. The program uses ...

7. soundsory.com soundsory.com/how-to-choose-listening-therapy-headphones-for-your-child-a-comprehensive-guide/

How to Choose Listening Therapy Headphones for Your ... A key advantage of bone conduction is its ability to provide faster sound transmission than air conduction, bypassing the external auditory ...

8. integratedlistening.com integratedlistening.com/products/focus-system/

Integrated Listening System (ILS) The ILS provides multisensory input through filtered classical music, delivered via air- and bone-conduction headphones and movement activities.