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

Not Applicable

• Conditions: H90.4; Sensorineural hearing loss, unilateral with unrestricted hearing on the contralateral side

• Registration Number: DRKS00014818
• Lead Sponsor: HNO-Uniklinik Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-30
• Study Completion: 2021-09-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>[15O]water PET are made while speech recognition un PET background noise.<br>

Secondary Outcome Measures

Name	Time	Method
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.<br>[15O]water PET are made while speech recognition un PET background noise.<br><br>2. Determination of differences in speech recognition in Oldenburg Noise and PET noise by means of audiometric testing (Oldenburger sentence's test, OLSA).<br>An audiological test to evaluate speech recognition in noise, OLSA, is performed with the Oldenburg noise and the recorded PET background noise.<br>