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…
ID
Bron
Verkorte titel
Aandoening
Intermittent tinnitus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Objective 1 to document the day by day changes of tinnitus that participants with intermittent tinnitus experience.
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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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
01-10-2016
Onderzoeksproduct en/of interventie
Not applicable
Publiek
E.A. Koops
Postbus 30.001
Groningen 9700 RB
The Netherlands
050-3616600
tinnitusapp@gmail.com
Wetenschappelijk
E.A. Koops
Postbus 30.001
Groningen 9700 RB
The Netherlands
050-3616600
tinnitusapp@gmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Adult, 18-75 years of age;
- Written informed consent.
- Group 1: participants with intermittent tinnitus.
- Group 2: participants with continuous tinnitus
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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);
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5951 |
| NTR-old | NTR6132 |
| Ander register | : METc 2016/293 |