Back to resultsTinnitus Treatment Using a Smartphone Application
Primary Purpose
Tinnitus, Subjective
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tinnitus application
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus, Subjective
Eligibility Criteria
Inclusion Criteria:
- Tinnitus lasting more than 3 months
Exclusion Criteria:
- Brain space occupying lesion
Sites / Locations
- Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment
Wait list
Arm Description
Outcomes
Primary Outcome Measures
Tinnitus Handicap Inventory score
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03688113
First Posted
September 26, 2018
Last Updated
December 28, 2019
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03688113
Brief Title
Tinnitus Treatment Using a Smartphone Application
Official Title
The Use of a Smartphone Application for Tinnitus Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Title
Wait list
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Tinnitus application
Intervention Description
Use of tinnitus application
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory score
Description
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)
Time Frame
34 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tinnitus lasting more than 3 months
Exclusion Criteria:
Brain space occupying lesion
Facility Information:
Facility Name
Sourasky Medical Center
City
Tel-Aviv
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tinnitus Treatment Using a Smartphone Application
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