- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03015870
Technology-assisted Vocal Exercise for Older Adults
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Illinois
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Champaign, Illinois, Forenede Stater, 61820
- University of Illinois at Urbana-Champaign
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Feedback
Behavioral: Vocal exercise with real-time feedback.
|
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.
|
Aktiv komparator: Recording
Behavioral: Vocal exercise with recording
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Vocal acoustic function
Tidsramme: 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
|
Vocal aerodynamic function
Tidsramme: 8-week change from baseline
|
Phonation threshold pressure (kPa)
|
8-week change from baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Program engagement and app usability
Tidsramme: 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.
|
8-week training period
|
Training-induced Change in Voice-related Quality of Life
Tidsramme: 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
|
Acceptability/feasibility of intervention
Tidsramme: 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")
|
Post-intervention (8-week follow-up)
|
Respiratory Function
Tidsramme: 8-week change from baseline
|
FEV1 - forced expiratory volume in 1 second (Liters)
|
8-week change from baseline
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Aaron M Johnson, PhD, University of Illinois at Urbana-Champaign
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Nøgleord
Andre undersøgelses-id-numre
- IRB15130
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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