TinnitusEMSLTNCT02684890
Detection of Emotions in a Spoken Language Among Tinnitus Patients
An observational study of Tinnitus, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Tinnitus may affect the ability of patients to detect emotions in spoken language. This study will compare this ability between tinnitus patients and non-tinnitus patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Tinnitus
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2016to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with tinnitus
Who may be able to join
- Tinnitus lasting 3 months and longer
- Hebrew speakers
Who cannot join
- Tinnitus which began less than 3 months ago Learned Hebrew after the age of 5
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson Medical Centre
Holon
Yahav Oron
Yahav Oron, MD
About this study
Tinnitus may affect the ability of patients to detect emotions in spoken language. This study will compare this ability between tinnitus patients and non-tinnitus patients.
- Conditions
- Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tinnitus patients | Patients with tinnitus lasting over 3 months | |
| Non-tinnitus patients | Patients without tinnitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion scores
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oron Yahav, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684890
- Sponsor's protocol ID
- 0220-15-WOMC
- Acronym
- EMSLT
- Status last verified
- Nov 2016
- First submitted
- 13 Feb 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Emotions in a Spoken Language Among Tinnitus Patients
- ClinicalTrials.gov ID
- NCT02684890
- Acronym / sponsor ID
- EMSLT / 0220-15-WOMC
- Conditions
- Tinnitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Mar 2016
- Primary completion
- Feb 2018 (estimated)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tinnitus may affect the ability of patients to detect emotions in spoken language. This study will compare this ability between tinnitus patients and non-tinnitus patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tinnitus patients | – | –Patients with tinnitus lasting over 3 months |
| Non-tinnitus patients | – | –Patients without tinnitus |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with tinnitus
Key inclusion criteria (2 listed)
- Tinnitus lasting 3 months and longer
- Hebrew speakers
Key exclusion criteria (1 listed)
- Tinnitus which began less than 3 months ago Learned Hebrew after the age of 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Emotion scores
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yahav Oron, MD (+972-3-5028651, oron.yahav@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion scores (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.