- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03015870
Technology-assisted Vocal Exercise for Older Adults
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
All participants will receive an iPad pre-loaded with an instructional PDF containing written instructions and embedded recorded audio prompts to assist with the delivery of an established vocal training paradigm, the Vocal Function Exercises (VFE) developed by Stemple.22 The VFE involves a set of four exercises focusing on extending maximum phonation time, increasing pitch range, and, therefore, improving coordination of the respiratory, phonatory, and resonatory systems during voicing. The iPads will be collected from the participants at the conclusion of the study at the post-intervention testing sessions.
Participants will be randomly assigned to either an experimental feedback group or active control no feedback group. Participants in the feedback group will receive iPads pre-loaded with Sonneta Voice Monitor app (MintLeaf Software) which will provide tailored feedback regarding pitch, loudness, and duration of phonation during practice sessions. The no feedback group will be provided with an iPad pre-installed with the PDF for the full duration of the study, but no feedback app.
Prior to and separate from the individual baseline testing appointments (described below), one group-based introductory session will be held to orient all participants to iPad controls (i.e., navigation, volume, recordings), as well as training specific to their assigned condition (how to use the pdf or app). Participants will complete a progressive weekly training schedule (3, 4, 5, 6, 7, 7, 7, & 7 days per week) 2x per day for 30-minute sessions over 8 weeks. The first training session will be monitored to provide technical assistance and ensure fidelity of the training protocol. Undergraduate research assistants from Dr. Johnson's lab will contact each participant via telephone on a weekly basis to provide technical assistance and confirm adherence to the training schedule.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Illinois
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Champaign, Illinois, États-Unis, 61820
- University of Illinois at Urbana-Champaign
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 65 years or older
- Vision at least 20/40 with glass or contacts
Exclusion Criteria:
- Moderate-severe cognitive impairment
- Currently engaged in regular daily singing practice
- Currently involved in a research study involving exercise, memory, or vocal strengthening
- Currently being treated for a voice disorder by either an ENT or SLP
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Feedback
Behavioral: Vocal exercise with real-time feedback.
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The feedback intervention will use iPads pre-installed with a PDF of vocal exercises for the full duration of the study and with an app which will provide tailored feedback regarding pitch, loudness, and duration of phonation during practice sessions.
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|
Comparateur actif: Recording
Behavioral: Vocal exercise with recording
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The recording intervention will use an iPad pre-installed with the PDF of vocal exercises for the full duration of the study, but no feedback app.Participants audio record self while performing vocal exercises
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Vocal acoustic function
Délai: 8-week change from baseline
|
Dysphonia Severity Index: composite measure of maximum phonation time (s), highest fundamental frequency (Hz), lowest intensity (dB) and jitter (%).
|
8-week change from baseline
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Vocal aerodynamic function
Délai: 8-week change from baseline
|
Phonation threshold pressure (kPa)
|
8-week change from baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Program engagement and app usability
Délai: 8-week training period
|
Assessed via self-report (and verified via objective data) weekly during intervention and computed as an un-weighted composite score reflecting 8-week program adherence and ease of use.
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8-week training period
|
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Training-induced Change in Voice-related Quality of Life
Délai: 8-week change from baseline
|
The London Chest Activity of Daily Living Scale will be used to assess theoretical and mechanistic components of the vocal exercise intervention.
Un-weight composite scores will be calculated at each assessment.
|
8-week change from baseline
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Acceptability/feasibility of intervention
Délai: Post-intervention (8-week follow-up)
|
Self-reported level of agreement (1 strongly disagree, 7 strongly agree) with three separate statements ("I enjoyed the program I used to exercise my voice," "I will continue to use the training techniques in the future," and "I believe my voice improved as a result of my participation in this program")
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Post-intervention (8-week follow-up)
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Respiratory Function
Délai: 8-week change from baseline
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FEV1 - forced expiratory volume in 1 second (Liters)
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8-week change from baseline
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Aaron M Johnson, PhD, University of Illinois at Urbana-Champaign
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
Mots clés
Autres numéros d'identification d'étude
- IRB15130
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .