Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tinnitus Treatment Using a Smartphone Application

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688113
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Brief Summary:
People with tinnitus will use a smartpphone app in which they are instructed to reject maladaptive thoughts by throwing them away from themselves (upwards) and embrace supportive thoughts by pulling them towards themselves (downwards). The Tinnitus Handicap Inventory will be used to measure the effect of the application.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Behavioral: Tinnitus application Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of a Smartphone Application for Tinnitus Treatment
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: Treatment Behavioral: Tinnitus application
Use of tinnitus application

Wait list Behavioral: Tinnitus application
Use of tinnitus application




Primary Outcome Measures :
  1. Tinnitus Handicap Inventory score [ Time Frame: 34 days ]
    The Tinnitus Handicap Inventory measures the degree of disturbance the tinnitus causes the patients, on a a total scale of 0-100. 0 is the lowest possible score (no disturbance caused by the tinnitus, 100- the most severe form of intrusiveness)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Tinnitus lasting more than 3 months

Exclusion Criteria:

  • Brain space occupying lesion

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): NCT03688113


Locations
Layout table for location information
Israel
Sourasky Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Layout table for additonal information
Responsible Party: michal roll, Director, Research and Development, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03688113    
Other Study ID Numbers: 0493-18-TLV
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases