- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03688113
Tinnitus Treatment Using a Smartphone Application
December 28, 2019 updated by: michal roll, Tel-Aviv Sourasky Medical Center
The Use of a Smartphone Application for Tinnitus Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tel-Aviv, Israel
- Sourasky Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Tinnitus lasting more than 3 months
Exclusion Criteria:
- Brain space occupying lesion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment
|
Use of tinnitus application
|
OTHER: Wait list
|
Use of tinnitus application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
34 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2018
Primary Completion (ACTUAL)
December 1, 2019
Study Completion (ACTUAL)
December 1, 2019
Study Registration Dates
First Submitted
September 26, 2018
First Submitted That Met QC Criteria
September 26, 2018
First Posted (ACTUAL)
September 28, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 28, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0493-18-TLV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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