NCT03688113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

September 26, 2018

Last Update Submit

December 28, 2019

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (1)

  • 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)

    34 days

Study Arms (2)

Treatment

EXPERIMENTAL
Behavioral: Tinnitus application

Wait list

OTHER
Behavioral: Tinnitus application

Interventions

Tinnitus applicationBEHAVIORAL

Use of tinnitus application

TreatmentWait list

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tinnitus lasting more than 3 months

You may not qualify if:

  • Brain space occupying lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Research and Development

Study Record Dates

First Submitted

September 26, 2018

First Posted

September 28, 2018

Study Start

December 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)