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 |