"Nuance Hearing" for Attention Deficit Hyperactivity Disorder (ADHD)

Technology Efficacy of "Nuance Hearing" Among Students Suffering From Attention Disorders- A Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Device: Nuance Phone case

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Nuance Phone case; "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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nuance Hearing
• Investigators: Principal Investigator: Iris Manor, phd, Geha Mental Health Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2019
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): February 1, 2020

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (ACTUAL): April 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Attention Deficit/Hyperactivity Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: NuanceADHD pilot

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No