- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01309503
Speech Intelligibility in Noise Using the Hearing in Noise Test (HINT)
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
-
Oslo, Norge
- Rekruttering
- Oslo University Hospital
-
Kontakt:
- Marte Myhrum, M.Sc
- Telefonnummer: 004723071691
- E-mail: marte.myhrum@oslo-universitetssykehus.no
-
Ledende efterforsker:
- Marte Myhrum, M.Sc
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria for the different groups:
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.
- 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.
Exclusion Criteria:
- None
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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 |
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marte Myhrum, M.Sc., Oslo University Hospital
- Studiestol: Greg Jablonski, PhD, Oslo University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2010/743a (REK )
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .