Tinnitus Treatment Using a Smartphone Application
Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03688113
Collaborator
(none)
31
1
2
12
2.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
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
:
Dec 1, 2018
Actual Primary Completion Date
:
Dec 1, 2019
Actual Study Completion Date
:
Dec 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment
|
Behavioral: Tinnitus application
Use of tinnitus application
|
| Other: Wait list
|
Behavioral: Tinnitus application
Use of tinnitus application
|
Outcome Measures
Primary Outcome Measures
- Tinnitus Handicap Inventory score [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)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Tinnitus lasting more than 3 months
Exclusion Criteria:
- Brain space occupying lesion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sourasky Medical Center | Tel-Aviv | Israel |
Sponsors and Collaborators
- Tel-Aviv Sourasky Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.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:
Sep 28, 2018
Last Update Posted:
Jan 2, 2020
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: