"Nuance Hearing" for Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

— ADHD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03902015
• Other study ID #: NuanceADHD pilot
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2019
• Est. completion date: February 2020

Study information

• Verified date: April 2019
• Source: Nuance Hearing
• Contact: Tami Harel, MA
• Phone: +972 54 477 8500
• Email: tami[@]nuancehear.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nuance Hearing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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