Evaluation of the CochSyn Device in Clinical Practice
A legfontosabb adatok
- Ki végzi
- University Ghent
- Hol
- Belgium3 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 65 fő vett részt
- Kezdés
- 2025. okt. 29.
- Befejezés
- 2026. jan. 22.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoport
- A vizsgált kezelések
- CochSyn device
- A regiszteradat frissítve
- 2026. február 10.
Ki vehet részt
- Életkor
- 18 év – 77 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Részt vehetnek
A regiszter feltételei, szó szerint
Mind a 20 feltétel megnézéseKevesebb
Ki vehet részt
- Age 18-77 years (limits included)
- Ability to fill out a questionnaire and to perform a speech intelligibility test
- Dutch or French as native language; Control group
- No self-reported hearing difficulties according to HHIE-s questionnaire (score of ≤4); Test group
- Self-reported hearing difficulties according to HHIE-s questionnaire (score of >4); Subgroup DFNA9:
- Genetically tested and confirmed to have DFNA9 related hearing loss. Note: This genetic testing was performed through standard of care testing, prior to participation in the study
Ki nem vehet részt
- Middle ear surgery on the tested ear
- Participation in session 2 of previous clinical trial NCT06114680
- Acute ear infection of the tested ear
- Audiometric hearing loss classifications of Moderate, Moderately severe, Severe, Profound as defined by (Clark, 1981) of the tested ear
- Asymmetrical hearing loss Note 1: Asymmetrical hearing loss is defined as an average difference of more than 15dB between both ears across the frequencies of 500, 1000, 2000 and 4000 Hz. The sum of loss in dB is divided by 4 and rounded up. A frequency not perceived is considered a loss of 120 dB; Note 2: This exclusion criterium is not applicable for the DFNA 9 subgroup
- Tinnitus with a clinical handicap index (TFI) > 25
- Patients with type AD, AS, B or C tympanograms
- Conductive hearing loss on the tested ear at the discretion of the investigator
- Genetic hearing loss of the tested ear Note: This exclusion criterium is not applicable for the DFNA9 subgroup
- Congenital hearing loss of the tested ear Note: This exclusion criterium is not applicable for the DFNA9 subgroup
- Blocked ear canal(s) of the tested ear
- Pregnant or breast-feeding
- Hearing aid user on the tested ear
- Acute external auditory canal trauma on the tested ear
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
This study investigates a new type of auditory evoked brain potentials for the quantification and classification of peripheral hearing damage (The CochSyn Test). The study will investigate the characteristics of this new auditory evoked potential marker in a cohort of people with and without self-reported hearing difficulties and test a new type of hardware that was developed to conduct the test (the CochSyn Device) in clinical practice.
A vizsgálat 3 csoportja
- Test group (self-reported hearing difficulties)A vizsgált kezelés
30 subjects with self-reported hearing difficulties according to the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-s) questionnaire (score of \>4)
Kezelés: CochSyn device
- Control group (no self-reported hearing difficulties)A vizsgált kezelés
30 subjects without self-reported hearing difficulties according to the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-s) questionnaire (score of ≤4)
Kezelés: CochSyn device
- DeaFNess Autosomal dominant 9 (DFNA9) subgroup (genetically tested and confirmed)A vizsgált kezelés
10 subjects (+3 potential drop-outs) genetically tested and confirmed to have DeaFNess Autosomal dominant 9 (DFNA9) related hearing loss
Kezelés: CochSyn device
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2026. február 10.