| |
Pre-screening
|
Screening
|
Baseline
|
Treatment start
|
Interim visit
|
Final visit = end of treatment
|
Follow-up
|
Additional follow-up
|
|---|
|
ICF
|
Aa
|
A
| | | | | | |
|
Eligibility criteria
|
A
|
A
|
A
| | | | | |
|
ESIT-SQ
| | |
A
| | | | | |
|
TSCHQ
| | |
B
| | | | | |
|
Mini TQ
|
A
|
A
|
A
| |
A
|
A
|
A
|
B
|
|
Tinnitus numeric rating scales
| |
A
|
A
| |
A
|
A
|
A
|
B
|
|
TFI
| |
A
|
A
| |
A
|
A
|
A
|
B
|
|
THI
|
A
|
A
|
A
| |
A
|
A
|
A
|
B
|
|
WhoQol-BREF
| |
A
|
A
| |
A
|
A
|
A
|
B
|
|
BFI-2
| | |
A
| | | | | |
|
CGI-I
| | | | |
A
|
A
|
A
|
B
|
|
GUF
| |
B
|
B
| |
B
|
B
|
B
|
B
|
|
PHQ-D
|
A
|
A
|
A
| |
A
|
A
|
A
|
B
|
|
Mini-SOISES
| | |
A
| |
A
|
A
|
A
|
B
|
|
ATAQ
| | |
Bb
| | |
Bb
| | |
|
FTQ
| | |
B
| |
B
|
B
|
B
|
B
|
|
MoCA
| |
A
| | | | | | |
|
Randomization
| | |
A
| | | | | |
|
Blood sampling
| | |
Bc
| | | | | |
|
Otological examination
| |
A
| | | |
A
|
B
|
B
|
|
Audiometry
| |
A
| | | |
A
|
B
|
B
|
|
Loudness match
| |
A
| | | |
A
|
B
|
B
|
|
Pitch match
| |
A
| | | |
A
|
B
|
B
|
|
Maskability
| |
A
| | | |
A
|
B
|
B
|
|
Residual inhibition
| |
A
| | | |
B
|
B
|
B
|
|
ABR
| | |
A
| | | |
B
|
B
|
|
AMLR
| | |
A
| | | |
B
|
B
|
|
Treatment
| | | |
A
|
A
|
A
| | |
|
Comorbidities
| |
A
|
A
|
A
|
A
|
A
|
A
|
B
|
|
Concomitant medication/ treatment
| |
A
|
A
|
A
|
A
|
A
|
A
|
B
|
|
Adverse events
| | | | |
A
|
A
|
A
|
B
|
- A mandatory; B voluntary; ICF Informed Consent Form; ESIT-SQ European School of Interdisciplinary Tinnitus Research Screening Questionnaire; TSCHQ Tinnitus Sample Case History; Mini-TQ Mini Tinnitus Questionnaire; TFI Tinnitus Functional Index; THI Tinnitus Handicap Inventory; WhoQol-BREF World Health Organization Quality of Life – abbreviated; BFI-2 Big Five Inventory-2; CGI-I Clinical Global Impression Scale – Improvement; GUF Questionnaire on Hypersensitivity to Sound; PHQ-D Patient Health Questionnaire for Depression; SOISES Social Isolation Electronic Survey; ATAQ Attitudes Towards Amplification Questionnaire; FTQ Fear of Tinnitus Questionnaire; MoCA Montreal Cognitive Assessment; ABR Auditory Brainstem Response; AMLR Auditory Middle Latency Response
- Screening and Baseline measurements as well as treatment start can be performed on the same day. In this case, all measurements are only performed once. The baseline should be maximum 4 weeks before the treatment start; otherwise, baseline measures should be repeated (without ESIT-SQ, TSCHQ, BFI-2, ATAQ, electrophysiological measurements). aDeclaration of consent (ICF) can be digital for the pre-screening. bOnly for participants who were allocated to a single or combinational treatment with HA. cBlood samples can be taken at any time point before treatment start
