Back to results"Nuance Hearing" for Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nuance Phone case
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit/Hyperactivity Disorder
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nuance Phone case
Arm Description
"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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03902015
Brief Title
"Nuance Hearing" for Attention Deficit Hyperactivity Disorder
Acronym
ADHD
Official Title
Technology Efficacy of "Nuance Hearing" Among Students Suffering From Attention Disorders- A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nuance Hearing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit/Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nuance Phone case
Arm Type
Experimental
Arm Description
"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.
Intervention Type
Device
Intervention Name(s)
Nuance Phone case
Intervention Description
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 Measure Information:
Title
Listening inventory for education - revised (L.I.F.E - R) 1 week after baseline
Description
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.
Time Frame
1 week after baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tami Harel, MA
Phone
+972 54 477 8500
Email
tami@nuancehear.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ori Goren
Phone
+972 54 490 2226
Email
ori@nuancehear.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Manor, phd
Organizational Affiliation
Geha Mental Health Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
"Nuance Hearing" for Attention Deficit Hyperactivity Disorder
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