NCT01309503

Brief Summary

The main purpose of the study is to estimate speech intelligibility in noise. A Norwegian Hearing in Noise Test (HINT) for children will be implemented, and test results for normal hearing (NH) children and adults will be collected. Test results for groups of hearing aid (HA) users and test results for cochlea implant (CI) users will be collected and compared to the NH group and between groups of HA users and CI users. A group of single sided hearing loss patients will also be included. Binaural benefits of two ears, two HAs and two CIs will be estimated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

3 years

First QC Date

March 3, 2011

Last Update Submit

March 28, 2011

Conditions

Study Arms (5)

Normal hearing

Children and adults

Unilateral hearing loss

Severe hearing loss high frequencies

Adult CI users

Unilateral and bilateral CI

Bilateral CI users

Children and adults Sequential CIs Simultaneous CIs

Eligibility Criteria

Age5 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients at the ENT department, Oslo University hospital, Rikshospitalet. Normal hearing group recruited from different schools and kindergartens.

You may qualify if:

  • Normal hearing group (note that some subjects are already recruited in the normal hearing group):
  • audiometric thresholds less than or equal to 25 dB HL for octave frequencies between 250 Hz and 8000 Hz
  • Adults between age 18 and 50 years
  • Children at different age groups between 6 and 12 years old
  • Unilateral hearing loss group
  • Single-sided hearing loss.
  • Using hearing aid or willing to try hearing aid on the side with hearing loss to estimate a potential binaural benefit with hearing aid.
  • Contralateral normal hearing with audiometric thresholds less than or equal to 25 dB HL for octave frequencies between 250 Hz and 8000 Hz
  • Group with Severe hearing loss at high frequencies
  • Adult CI users with unilateral and bilateral CI
  • All adult patients will be tested to the level of their performance.
  • HINT SRTs will be collected if HINT score in quiet is above 70%.
  • Bilateral CI users (Children)
  • Sequential CIs group
  • Children that has got two CIs in two different operations, and operations are not within one year.
  • +4 more criteria

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo university hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Speech Intelligibility

Condition Hierarchy (Ancestors)

SpeechVerbal BehaviorCommunicationBehavior

Study Officials

  • Marte Myhrum, M.Sc.

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR
  • Greg Jablonski, PhD

    Oslo University Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 7, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

March 29, 2011

Record last verified: 2011-03

Locations