No registrations found.
ID
Source
Brief title
Health condition
Intermittent tinnitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective 1 to document the day by day changes of tinnitus that participants with intermittent tinnitus experience.
Objective 2: to document whether the changes in tinnitus co-occur with changes in functional brain connectivity, and whether brain connectivity patterns differ from those in participants with continuous tinnitus.
Secondary outcome
Not applicable
Background summary
Part 1: Participants receive an iPhone/Android app, which they use for 30 days. The app prompts them 3 times per day to fill in a brief questionnaire on their tinnitus. Filling in the questionnaires takes about 15 seconds. This has no benefit to the participant, except that the app provides an overview of results to the participants that is informative about their own tinnitus characteristics.
Part 2: A subgroup of participants from part 1 will be invited to participate in an fMRI experiment. This involves filling in 5 standard clinical questionnaires (30 minutes), 1 standard MRI compatibility questionnaire (5 minutes), measuring an audiogram (20 minutes) and two fMRI session in a 3.0 Tesla MRI scanner (30 minutes each). This part provides no individual benefit to the patient. We rate the inconvenience as mild. None of the procedures expose the participants to known risks.
Study objective
Objective 1 to document the day by day changes of tinnitus that participants with intermittent tinnitus experience.
Objective 2: to document whether the changes in tinnitus co-occur with changes in functional brain connectivity, and whether brain connectivity patterns differ from those in participants with continuous tinnitus.
Study design
01-10-2016
Intervention
Not applicable
E.A. Koops
Postbus 30.001
Groningen 9700 RB
The Netherlands
050-3616600
tinnitusapp@gmail.com
E.A. Koops
Postbus 30.001
Groningen 9700 RB
The Netherlands
050-3616600
tinnitusapp@gmail.com
Inclusion criteria
- Adult, 18-75 years of age;
- Written informed consent.
- Group 1: participants with intermittent tinnitus.
- Group 2: participants with continuous tinnitus
Exclusion criteria
-Non-conformance to any of the inclusion criteria stated above
-Contraindications for MRI according to the MRI checklist
-Reported medical, neurological, or psychiatric disorders (excluding tinnitus and hearing loss);
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5951 |
| NTR-old | NTR6132 |
| Other | : METc 2016/293 |