Development of Software to Provide the SpeechVive Device Via the Internet
18 september 2019 bijgewerkt door: SpeechVive, Inc
Development of a Telehealth Platform for Treatment With the SpeechVive Device
Telehealth, increasingly recognized in the neurology field as a solution to access issues for people with Parkinson's disease, improves access to speech therapy, particularly those living in rural areas or with travel barriers.
The SpeechVive device, developed by SpeechVive, Inc., is a treatment solution that is easy to use and effective.
In an NIH funded study, the SpeechVive device improved communication in 90% of individuals with PD by improving volume, articulation, and speech rate.
The investigators propose to eliminate the one drawback of the SpeechVive device, namely that it currently must be programmed by a speech-language pathologist for each patient in person.
The overall goal of this project is to develop a telehealth platform for the SpeechVive device that will enable video conferencing for treatment and remote programming of the SpeechVive device for each patient.
Once the platform has been developed, the investigators will conduct a study to examine effectiveness and the patient and caregiver satisfaction with telepractice using the SpeechVive device.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
143
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Indiana
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Lafayette, Indiana, Verenigde Staten, 47905
- SpeechVive, Inc
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West Lafayette, Indiana, Verenigde Staten, 47907
- Purdue University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
30 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Diagnosis of Parkinson's disease
- Difficulty communicating
- Is currently being seen, or agrees to be seen, by a speech pathologist who fits the SpeechVive device and also has agreed to participate in the study
- Has a regular caregiver living with him/her
Exclusion Criteria:
- Neurological diagnoses (except Parkinson's disease)
- Bilateral hearing aids (since one free ear is required for use of the SpeechVive device)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Telemedicine group
People with Parkinson's disease and their caregivers obtaining treatment using the SpeechVive device via the internet using the telemedicine application.
Also includes speech-language pathologists providing treatment via the telemedicine application.
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The SpeechVive is a wearable device that plays multi-talker babble noise in one ear while the person wearing it is talking.
The noise is voice-activated (only present when the person speaks).
The noise does not interfere with the ability to hear communication partners.
The noise coming from the device functions as a natural external cue for people with Parkinson's disease to talk more loudly and clearly.
Treatment will involve asking the participants to wear the device daily during the treatment period.
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
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Actieve vergelijker: In person group
People with Parkinson's disease and their caregivers obtaining treatment using the SpeechVive device in person.
Also includes speech-language pathologists providing treatment in person.
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The SpeechVive is a wearable device that plays multi-talker babble noise in one ear while the person wearing it is talking.
The noise is voice-activated (only present when the person speaks).
The noise does not interfere with the ability to hear communication partners.
The noise coming from the device functions as a natural external cue for people with Parkinson's disease to talk more loudly and clearly.
Treatment will involve asking the participants to wear the device daily during the treatment period.
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Caregiver Quality of Life
Tijdsspanne: Change from baseline after 6 months of treatment
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Scale of Quality of Life of Care-givers
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Change from baseline after 6 months of treatment
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Depression: Caregiver Geriatric Depression Scale
Tijdsspanne: Change from baseline after 6 months of treatment
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Geriatric Depression Scale
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Change from baseline after 6 months of treatment
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Change in Patient with PD Ratings of Communication Competence
Tijdsspanne: Change from baseline after 6 months of treatment
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Communicative Participation Item Bank-Short Form
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Change from baseline after 6 months of treatment
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Change in Patient with PD quality of life
Tijdsspanne: Change from baseline after 6 months of treatment
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Parkinson's Disease Questionnaire-39
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Change from baseline after 6 months of treatment
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Attractiveness of the telehealth platform.
Tijdsspanne: At monthly intervals during the study period (6 months for each patient)
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Survey requesting SLP data regarding patients seen during the study period and adoption of the telepractice model by patients
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At monthly intervals during the study period (6 months for each patient)
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Travel cost burden - in-person group
Tijdsspanne: At monthly intervals during the study period (6 months for each patient)
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Survey requesting Patient/caregiver travel distances and durations
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At monthly intervals during the study period (6 months for each patient)
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Impact of treatment on time - telemedicine group
Tijdsspanne: At monthly intervals during the study period (6 months for each patient)
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Survey requesting Patient and caregiver reports of time spent before and after sessions preparing and setting up equipment and clearing equipment
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At monthly intervals during the study period (6 months for each patient)
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Treatment adherence
Tijdsspanne: At monthly intervals during the study period (6 months for each patient)
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Usage data from the SpeechVive and patient attendance at treatment sessions
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At monthly intervals during the study period (6 months for each patient)
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Change in Vocal intensity level
Tijdsspanne: Change from baseline after 6 months of treatment
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Sound pressure level from speech samples with and without the device in place
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Change from baseline after 6 months of treatment
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Change in Patient with PD Depression Level
Tijdsspanne: Change from baseline after 6 months of treatment
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Geriatric Depression Scale Short form
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Change from baseline after 6 months of treatment
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Impact of Life Events for Patient with PD and Caregiver
Tijdsspanne: Change from baseline after 6 months of treatment
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Change in Impact of PD on life satisfaction
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Change from baseline after 6 months of treatment
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Change in general self-efficacy
Tijdsspanne: Change from baseline after 6 months of treatment
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Self-efficacy for people with disabilities scale
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Change from baseline after 6 months of treatment
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Speech rate
Tijdsspanne: Change from baseline after 6 months of treatment
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Rate of speech from speech samples with and without the device in place
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Change from baseline after 6 months of treatment
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Change in Pausing patterns
Tijdsspanne: Change from baseline after 6 months of treatment
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Number and duration of silent and filled pauses from speech samples with and without the device in place
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Change from baseline after 6 months of treatment
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Change in Caregiver Burden
Tijdsspanne: Change from baseline after 6 months of treatment
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Caregiver Burden Inventory
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Change from baseline after 6 months of treatment
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Change in Apathy
Tijdsspanne: Change in baseline after 6 months of treatment for Patient with PD and Caregiver
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Apathy Scale
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Change in baseline after 6 months of treatment for Patient with PD and Caregiver
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Change in Caregiver Ratings Patient's of Communication Competence
Tijdsspanne: Change in baseline after 6 months of treatment
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Communicative Participation Item Bank-Short Form
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Change in baseline after 6 months of treatment
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Change in Patient with PD Participation in Social Activities
Tijdsspanne: Change in baseline after 6 months of treatment
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Quality of Life in Neurological Disorders (Neuro-QOL)
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Change in baseline after 6 months of treatment
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Change in Patient with PD Participation in Social Activities
Tijdsspanne: Change in baseline after 6 months of treatment
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Ability to Participate in Social Roles and Activities-Short Form
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Change in baseline after 6 months of treatment
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Change in Patient with PD Perceived Autonomy
Tijdsspanne: Change in baseline after 6 months of treatment
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7-item Autonomy Subscale of the Basic Psychological Needs Scale
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Change in baseline after 6 months of treatment
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Patient with PD satisfaction - telemedicine group
Tijdsspanne: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the telemedicine application and treatment process
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At the end of the study period (after 6 months)
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Caregiver satisfaction - telemedicine group
Tijdsspanne: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the telemedicine application and treatment process
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At the end of the study period (after 6 months)
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Patient with PD satisfaction - in person group
Tijdsspanne: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the in-person treatment process
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At the end of the study period (after 6 months)
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Caregiver satisfaction - in person group
Tijdsspanne: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the in-person treatment process
|
At the end of the study period (after 6 months)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Stathopoulos ET, Huber JE, Richardson K, Kamphaus J, DeCicco D, Darling M, Fulcher K, Sussman JE. Increased vocal intensity due to the Lombard effect in speakers with Parkinson's disease: simultaneous laryngeal and respiratory strategies. J Commun Disord. 2014 Mar-Apr;48:1-17. doi: 10.1016/j.jcomdis.2013.12.001. Epub 2013 Dec 28.
- Huber JE, Darling M, Francis EJ, Zhang D. Impact of typical aging and Parkinson's disease on the relationship among breath pausing, syntax, and punctuation. Am J Speech Lang Pathol. 2012 Nov;21(4):368-79. doi: 10.1044/1058-0360(2012/11-0059). Epub 2012 Jul 30.
- Darling M, Huber JE. Changes to articulatory kinematics in response to loudness cues in individuals with Parkinson's disease. J Speech Lang Hear Res. 2011 Oct;54(5):1247-59. doi: 10.1044/1092-4388(2011/10-0024). Epub 2011 Mar 8.
- Huber JE, Darling M. Effect of Parkinson's disease on the production of structured and unstructured speaking tasks: respiratory physiologic and linguistic considerations. J Speech Lang Hear Res. 2011 Feb;54(1):33-46. doi: 10.1044/1092-4388(2010/09-0184). Epub 2010 Sep 15.
- Sadagopan N, Huber JE. Effects of loudness cues on respiration in individuals with Parkinson's disease. Mov Disord. 2007 Apr 15;22(5):651-9. doi: 10.1002/mds.21375.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
26 januari 2018
Primaire voltooiing (Werkelijk)
15 juni 2019
Studie voltooiing (Werkelijk)
15 juni 2019
Studieregistratiedata
Eerst ingediend
6 april 2016
Eerst ingediend dat voldeed aan de QC-criteria
19 april 2016
Eerst geplaatst (Schatting)
20 april 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 september 2019
Laatste update ingediend die voldeed aan QC-criteria
18 september 2019
Laatst geverifieerd
1 september 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1R44DC014867-01A1 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
The data from the people with Parkinson's disease and their caregivers will include limited financial information, perceptions of speech telepractice, survey data, and some objective measurements of speech production. Once de-identified and published in peer-reviewed journals, these data will be made available upon request. Any researcher requesting access to these data will need to submit the following to Jessica Huber:
- Name and institution of PI
- Proof of institutional appointment
- Names and roles for all individuals who will access the data for the planned analysis
- Detailed plan for the use of the data
- Timeline for use and publication of the analyses If Dr. Huber approves the data use, the PI must sign a license with Purdue University's Office of Technology Commercialization promising to keep the data confidential, to not share it with anyone not named in the application above, and to destroy the data once analysis is complete.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .