"Nuance Hearing" for Attention Deficit Hyperactivity Disorder (ADHD)
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|ClinicalTrials.gov Identifier: NCT03902015|
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Device: Nuance Phone case||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|Contact: Tami Harel, MA||+972 54 477 firstname.lastname@example.org|
|Contact: Ori Goren||+972 54 490 email@example.com|
|Principal Investigator:||Iris Manor, phd||Geha Mental Health Center|