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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902015
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Nuance Hearing

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Device: Nuance Phone case Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Technology Efficacy of "Nuance Hearing" Among Students Suffering From Attention Disorders- A Pilot Study
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Listening inventory for education - revised (L.I.F.E - R) 1 week after baseline [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902015


Contacts
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Contact: Tami Harel, MA +972 54 477 8500 tami@nuancehear.com
Contact: Ori Goren +972 54 490 2226 ori@nuancehear.com

Sponsors and Collaborators
Nuance Hearing
Investigators
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Principal Investigator: Iris Manor, phd Geha Mental Health Center
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Responsible Party: Nuance Hearing
ClinicalTrials.gov Identifier: NCT03902015    
Other Study ID Numbers: NuanceADHD pilot
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nuance Hearing:
Attention Deficit/Hyperactivity Disorder
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases