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Characteristics of intermittent tinnitus


- candidate number24736
- NTR NumberNTR6132
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-aug-2016
- Secondary IDsMETc 2016/293 
- Public TitleCharacteristics of intermittent tinnitus
- Scientific TitleEXPLORING THE PERCEPTUAL AND NEUROPHYSIOLOGICAL CHARACTERISTICS OF INTERMITTENT TINNITUS
- ACRONYMintermittenttinnitus
- hypothesisObjective 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.
- Healt Condition(s) or Problem(s) studiedIntermittent tinnitus
- 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);
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type[default]
- Studytype[default]
- planned startdate 1-sep-2016
- planned closingdate1-sep-2018
- Target number of participants220
- InterventionsNot applicable
- Primary outcomeObjective 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 outcomeNot applicable
- Timepoints01-10-2016
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESdrs. E.A. Koops
- CONTACT for SCIENTIFIC QUERIESdrs. E.A. Koops
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
NWO
- Publications
- Brief summaryPart 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.
- Main changes (audit trail)
- RECORD4-aug-2016 - 3-jan-2017


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