Tinnitus, SubjectiveTinnitusTipsNCT04069364
Systematic Assessment of Self-help Tools for the Management of Chronic Tinnitus
A study testing TinnitusTipps in people with Tinnitus, Subjective, run by University Hospital Regensburg at 1 site in Germany.
Trial summary
With this study we want to investigate the impact of self-help tools on the subjective tinnitus distress in chronic tinnitus patients. Furthermore, we want to investigate the influence of personal characteristics on the individual tinnitus improvement. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- TinnitusTipps
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 29 Apr 2019to 31 Mar 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- chronic tinnitus, duration at least 6 monhts
Who cannot join
- acute psychosis, depression, substance abuse
- psychopharmaca
- epilepsy or other disease of the central nervous system
- other tinnitus treatments in the last 3 months
- drug, medication or alcohol abuse in the last 12 weeks
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Regensburg
Regensburg
Winfried Schlee, PD DR, 00 49 941 9412096, winfried.schlee@tinnitusresearch.org
About this study
Official title: Systematische Untersuchung Zum Einfluss Von Selbsthilfe Auf Die Subjektive Belastung Bei Chronischem Tinnitus
With this study we want to investigate the impact of self-help tools on the subjective tinnitus distress in chronic tinnitus patients.
Furthermore, we want to investigate the influence of personal characteristics on the individual tinnitus improvement.
Read the detailed description
A smart-phone app running on iOS devices will be used to give self-help tips to the chronic tinnitus patients.
- Conditions
- Tinnitus, Subjective
- Being tested
- TinnitusTipps
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TinnitusTippsBehavioural
Self-helf tips for managing chronic tinnitus will be given via smartphones.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Tinnitus Handicap Inventory
Questionnaire
Measured: Before, after 4 months, and after 6 months
Change of Tinnitus Numeric Rating Scale
Questionnaire
Measured: Before, after 4 months, and after 6 months
Change Clinical Global Impression
Questionnaire
Measured: Before, after 4 months, and after 6 months
Secondary outcomes (1)
Change of WHO Quality of Life
Questionnaire
Measured: Before, after 4 months, and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start29 Apr 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winfried Schlee, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069364
- Sponsor's protocol ID
- 17-544-101
- Acronym
- TinnitusTips
- Status last verified
- Aug 2019
- First submitted
- 29 Apr 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematische Untersuchung Zum Einfluss Von Selbsthilfe Auf Die Subjektive Belastung Bei Chronischem Tinnitus
- ClinicalTrials.gov ID
- NCT04069364
- Acronym / sponsor ID
- TinnitusTips / 17-544-101
- Conditions
- Tinnitus, Subjective
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 28 Aug 2019 (actual)
- 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.
With this study we want to investigate the impact of self-help tools on the subjective tinnitus distress in chronic tinnitus patients.
Furthermore, we want to investigate the influence of personal characteristics on the individual tinnitus improvement.
Detailed description
A smart-phone app running on iOS devices will be used to give self-help tips to the chronic tinnitus patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic tinnitus, duration at least 6 monhts
Key exclusion criteria (5 listed)
- acute psychosis, depression, substance abuse
- psychopharmaca
- epilepsy or other disease of the central nervous system
- other tinnitus treatments in the last 3 months
- drug, medication or alcohol abuse in the last 12 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TinnitusTippsSelf-helf tips for managing chronic tinnitus will be given via smartphones. | Behavioural | – |
Primary outcome
Change of Tinnitus Handicap Inventory
Time frame: Before, after 4 months, and after 6 months
Questionnaire
Change of Tinnitus Numeric Rating Scale
Time frame: Before, after 4 months, and after 6 months
Questionnaire
Change Clinical Global Impression
Time frame: Before, after 4 months, and after 6 months
Questionnaire
1 secondary outcome
Change of WHO Quality of Life
Time frame: Before, after 4 months, and after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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?
A study testing TinnitusTipps in people with Tinnitus, Subjective, run by University Hospital Regensburg at 1 site in Germany.
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 1 inclusion and 5 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 28 Aug 2019. 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 Germany. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Tinnitus Handicap Inventory (time frame: Before, after 4 months, and after 6 months). The study lists 3 primary outcomes in all. 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 28 Aug 2019.