Speech IntelligibilityNCT01309503
Speech Intelligibility in Noise Using the Hearing in Noise Test (HINT)
An observational study of Speech Intelligibility, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech Intelligibility
- How many people
- 600 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2011to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients at the ENT department, Oslo University hospital, Rikshospitalet. Normal hearing group recruited from different schools and kindergartens.
Who may be able to join
- 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.
Show all 22Show fewer
- Using hearing aid or willing to try hearing aid on the side with hearing loss to estimate a potential binaural benefit with hearing aid.
- Unilateral hearing loss inclusion criteria is thresholds within 25 dBHL and 70 dBHL for frequencies {125,250,500} Hz. Inclusion region increasing linearly with octave frequency to 40 dBHL and 95 dBHL for frequency 8000Hz. In addition a single threshold outside this hearing threshold inclusion region is accepted.
- 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
- Inclusion criteria is bilateral hearing loss within hearing levels where frequencies below 750 Hz can be normal or elevated down to 65 dBHL, for frequencies 1000 Hz and 1500 Hz all HL thresholds are accepted, frequencies 2000 Hz and above have threshold criteria 85 dBHL or above.
- 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.
- Inclusion of some of the patients participating in another ongoing sequential CI-study at the ENT department,and who has a HINT score above 70% in quiet. The requirement of a quiet percentage score above 70% is due to the bilateral benefit testing/estimation.
- Simultaneous CIs group
- All children that has got two CIs in the same operation or sequentially within one year.
- Children older than 6 years old.
- Children as young as 5.5 years old can be included if they are considered ready for extended HINT testing.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo university hospital
Oslo
Marte Myhrum, M.Sc, 004723071691, marte.myhrum@oslo-universitetssykehus.no
Marte Myhrum, M.Sc
About this study
Official title: Speech Intelligibility in Noise and Estimation of Binaural Benefits Using the Hearing in Noise Test (HINT). Studies on Normal Hearing Children and Adults, Groups of Hearing Aid Users and Cochlea Implant Users.
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.
- Conditions
- Speech Intelligibility
- Medical subject headings
- Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal hearing | Children and adults | |
| Unilateral hearing loss | Not described | |
| Severe hearing loss high frequencies | Not described | |
| Adult CI users | Unilateral and bilateral CI | |
| Bilateral CI users | Children and adults Sequential CIs Simultaneous CIs |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech IntelligibilityStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Investigators
- Marte Myhrum, M.Sc., Principal investigator, Oslo University HospitalGreg Jablonski, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309503
- Sponsor's protocol ID
- 2010/743a (REK )
- Status last verified
- Mar 2011
- First submitted
- 3 Mar 2011
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Intelligibility in Noise and Estimation of Binaural Benefits Using the Hearing in Noise Test (HINT). Studies on Normal Hearing Children and Adults, Groups of Hearing Aid Users and Cochlea Implant Users.
- ClinicalTrials.gov ID
- NCT01309503
- Acronym / sponsor ID
- 2010/743a (REK )
- Conditions
- Speech Intelligibility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at the ENT department, Oslo University hospital, Rikshospitalet. Normal hearing group recruited from different schools and kindergartens.
Key inclusion criteria (22 listed)
- Normal hearing group (note that some subjects are already recruited in the normal hearing group):
- Unilateral hearing loss group
- Group with Severe hearing loss at high frequencies
- Adult CI users with unilateral and bilateral CI
- Bilateral CI users (Children)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marte Myhrum, M.Sc. principal investigator
Oslo University Hospital
Greg Jablonski, PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Speech Intelligibility, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marte Myhrum, M.Sc (004723071691, marte.myhrum@oslo-universitetssykehus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2011.