NCT01780025

Brief Summary

The purpose of this study is to measure objectively the coupling from direct acoustic cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked potentials.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2013

Enrollment Period

8.6 years

First QC Date

January 28, 2013

Last Update Submit

January 26, 2023

Conditions

Mixed Hearing Loss

Keywords

HearingThresholdsCoupling to the inner ear

Outcome Measures

Primary Outcomes (1)

  • auditory evoked potentials

    1 - 3 - 6 months

Secondary Outcomes (1)

  • speech audiometry

    3 and 6 months

Study Arms (1)

Mixed hearing loss

Behavioral: Auditory evoked potentials and audiometryBehavioral: Auditory evoked potentials

Interventions

Auditory evoked potentials and audiometryBEHAVIORAL
Mixed hearing loss
Auditory evoked potentialsBEHAVIORAL

Different protocols for audiometry and auditory evoked potentials

Mixed hearing loss

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mixed hearing loss

You may qualify if:

  • adults
  • mixed hearing loss

You may not qualify if:

  • children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Hearing Loss, Mixed Conductive-Sensorineural

Interventions

Evoked Potentials, AuditoryHearing

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Evoked PotentialsCortical ExcitabilityElectrophysiological PhenomenaPhysiological PhenomenaVestibulocochlear Physiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensation

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 30, 2013

Study Start

April 1, 2012

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

January 27, 2023

Record last verified: 2013-01

Locations

BE(1)