- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00371839
Clinical Applications for Time-Compressed Speech Tests
The purpose of this study is to determine the effects of age-related cognitive changes on hearing aid benefit based on hearing aid compression time constants.
The hypothesis is that people with poor working memory skills will benefit from slow time constants in hearing aid compression while those with good working memory skills will be able to benefit from more sophisticated compression algorithms with rapid time constants.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Recent research has shown the relevance of cognitive function in hearing aid evaluation and the sensitivity of the aging auditory system to temporal distortions. The proposed investigation will examine the interaction of working memory and hearing aid compression method on speech recognition in background competition for older listeners. This interaction will be investigated for the following three forms of background competition:
- Competition from continuous speech-shaped noise.
- Competition from speech-modulated noise.
- Competition from a single interfering talker.
The goals of the study will be accomplished in two phases. In the first phase, 160 adults aged 50 through 75 years will be evaluated on a battery of tests to determine their cognitive capacity, time-compressed speech scores and their candidacy for inclusion in the second phase of the study. At the conclusion of this phase of testing, the participants will be divided into three groups:
- subjects with TCS test scores in the highest quartile (the HIGH group)
- subjects with TCS test scores in the lowest quartile (the LOW group)
- the remaining listeners
The second phase of the experiment will include listeners from the HIGH and LOW groups only. These subjects will be evaluated with respect to their speech recognition ability for three types of interference (steady-state noise, speech-modulated noise, single interfering talker). The HINT test (Nilsson, Soli, & Sumida, 1995; Nilsson et al., 1994) will be used to obtain the signal-to-noise ratio (SNR) at 50% recognition for the three masking conditions for each of three types of amplification:
- one- channel linear amplification (LINEAR) with frequency shaping
- two-channel wide dynamic range compression with fast time constants (FAST)
- two-channel wide dynamic range compression with slow time constants (SLOW) Listener groups will be compared across hearing aid conditions and across background interference conditions.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Participants will be 50 to 75 years old.
- Hearing loss will be limited to 40 dB HL from 250 Hz through 1000 Hz, and to 60 dB HL through 4000 Hz.
- Hearing loss must be greater than 25 dB at two or more frequencies from 250 to 4000 Hz.
Exclusion Criteria:
- None of the participants will be current or past hearing aid users; all will be free of ear disease.
- Participants with conductive hearing losses, defined as air-bone gap greater than 15 dB, will be excluded.
- The audiometric battery with acoustic reflex thresholds and decay measurements will be used to exclude anyone with evidence of a central disorder or a pathology other than a sensorineural loss. Those potential participants will be referred to a medical professional.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Mild Hearing Loss
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 20-39 decibels hearing level (dBHL)
|
Tests of hearing, cognition, and speech perception
|
Comparateur actif: Moderate Hearing Loss
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 40-49 decibels hearing level (dBHL)
|
Tests of hearing, cognition, and speech perception
|
Comparateur actif: Moderate-Severe Hearing Loss
Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz greater than 50 decibels hearing level (dBHL)
|
Tests of hearing, cognition, and speech perception
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Ability to Understand Speech in Noise Background
Délai: one year
|
Measure speech perception for sentences in background noise
|
one year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marjorie R. Leek, PhD, VA Loma Linda Healthcare System, Loma Linda, CA
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- C4338-R
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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