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PET activation studies in unilaterally deaf CI patients for the detection of binaural interaction in acoustic and electrical stimulation

PET activation studies in unilaterally deaf CI patients for the detection of binaural interaction in acoustic and electrical stimulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014818
Enrollment
30
Registered
2018-10-30
Start date
2019-03-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H90.4

Interventions

Group 1: 20 CI (cochlear implant) recipients with unilateral severe hearing impairment to single-sided deafness and normal hearing on the contralateral side Group 2: 10 bilaterally normal-hearing subj

Sponsors

HNO-Uniklinik Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: SSD-CI recipients - Unilateral CI on the left hand side - Listening experience with the CI of at least 6 months - Hearing performance of the better-hearing ear: air conduction pure tone threshold from 125 Hz to 4 kHz of equal to or less than 30 dB HL and Freiburg monosyllabic word recognition at 65 dB SPL of equal to or more than 80 % - Hearing performance of the unaided poorer-hearing ear: air conduction pure tone threshold from 125 Hz to 4 kHz of equal to or more than 70 dB HL and Freiburg monosyllabic word recognition at 65 dB SPL of equal to or less than 30 % The classification into groups of better and poorer performers will be assigned based on the performance in the Oldenburg sentence test (OlSa) (median split). NH subjects - Hearing performance of both ears: air conduction pure tone threshold from 125 Hz to 8 kHz of equal to or less than 20 dB HL - Speech intelligibility threshold in the OlSa at S0N0 (fixed noise level of 65dB SPL and a start speech level of 65dB SPL): monaural left: = -6 dB, monaural right: = -6 dB and binaural: = -6 dB

Exclusion criteria

Exclusion criteria: Both groups - Age between 18 and 65 years - native language not German - Left-handers (Edinburgh Handedness inventory: score<60) - Relevant neurological or psychiatric accompanying illness (e. g. cognitive impairment, epilepsy, cerebrovascular disease, brain tumour, depression, etc.) - Diseases that can be expected to cause inadequate compliance with PET (e. g. back problems, severe claustrophobia, incontinence, etc.) - Pregnancy, breastfeeding, current desire to conceive a child - Past study-associated radiation exposure - Occupational radiation exposure

Design outcomes

Primary

MeasureTime frame
Determination of differences and similarities of central nervous processes during binaural interaction (speech recognition in PET (positron emission tomography) background noise) between SSD-CI (SSD = single sided deafness) recipients and NH (normal-hearing) subjects by means of [15O]water PET. [15O]water PET are made while speech recognition un PET background noise.

Secondary

MeasureTime frame
1. Identification of differences and similarities of central nervous processes during binaural interaction between SSD-CI recipients with good and poor performance by means of [15O]water PET. [15O]water PET are made while speech recognition un PET background noise. 2. Determination of differences in speech recognition in Oldenburg Noise and PET noise by means of audiometric testing (Oldenburger sentence's test, OLSA). An audiological test to evaluate speech recognition in noise, OLSA, is performed with the Oldenburg noise and the recorded PET background noise.

Countries

Germany

Contacts

Public ContactIva Speck

HNO-Uniklinik Freiburg

iva.speck@uniklinik-freiburg.de0761/270-41964

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026