"Nuance Hearing" for Attention Deficit Hyperactivity Disorder

NCT03902015 | Unknown

• 1 other identifier: NuanceADHD pilot
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the current study is to examine whether the ability to avoid irrelevant auditory stimuli and focus hearing, enabled by the device developed by "Nuance Hearing", may help students with ADHD in classroom listening situations by significantly reducing background distractions.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Listening inventory for education - revised (L.I.F.E - R) 1 week after baseline

  A self-assessment questionnaire for school aged children. This version of the questionnaire was developed to assess effectiveness of sound enhancement devices in the school and other social activities. The questionnaire is comprised of 10 items (for example - how well could you hear the words the teacher is saying when there is noise from the hallway") rated in a scale of 0 to 10, where 10 - always easy and 0- always difficult.

  1 week after baseline

Study Arms (1)

Nuance Phone case

EXPERIMENTAL

"Nuance Hearing" has developed a technology enabling focused hearing. The Selective Noise Cancellation (SNC) technology consists of an advanced beam-forming algorithm that tones down the ambient sound by up to 15 decibels (dB) in order to focus on a primary audio source. The device consists of a special phone case(for iPhone) containing microphone array. Controlling the direction of focus is enabled through the use of a designated app. The user can place the phone case on his/hers table and can choose the direction of preferred listening, without having to ask the talker to hold the device.

Device: Nuance Phone case

Interventions

Nuance Phone case DEVICE

participants will receive a phone (iPhone) with the Nuance Phone case and a designated app required for the use of the device. Participants will first undergo hearing test via the app, and afterwards (in case they are not excluded based on hearing status), will receive a introduction on how to use the app and the device. Before starting the clinical trial, children will undergo three adjustments days in which they will practice using the device in school. During this period the researchers will make sure that the participants are adapting to the use of the device, and in any case there is a problem, will be able to contact a representative of "Nuance Hearing" who will be available to support technical issues.

Nuance Phone case

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of attention deficit hyperactivity disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM IV)
• Have fulfilled the "Test of variables of attention"
• with normal hearing

You may not qualify if:

• Moderate to severe co-morbid psychiatric disorders
• Neurological chronic disease

Sponsors & Collaborators

• Nuance Hearing: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Iris Manor, phd

  Geha Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tami Harel, MA

CONTACT

+972 54 477 8500; tami@nuancehear.com

Ori Goren

CONTACT

+972 54 490 2226; ori@nuancehear.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 3, 2019
• Study Start: May 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 3, 2019

Record last verified: 2019-04