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Clinical Trials/DRKS00014818
DRKS00014818
Completed
未知

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

HNO-Uniklinik Freiburg0 sites30 target enrollmentOctober 30, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
H90.4
Sponsor
HNO-Uniklinik Freiburg
Enrollment
30
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 30, 2018
End Date
September 10, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
HNO-Uniklinik Freiburg

Eligibility 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).

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

Outcomes

Primary Outcomes

Not specified

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