Development of Software to Provide the SpeechVive Device Via the Internet

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: SpeechVive device; Behavioral: Telemedicine interaction; Behavioral: In person interaction

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Lafayette, Indiana, United States, 47905
      • SpeechVive, Inc
    • West Lafayette, Indiana, United States, 47907
      • Purdue University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: SpeechVive device; 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.; Behavioral: Telemedicine interaction; Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
Active Comparator: 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.	Device: SpeechVive device; 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.; Behavioral: In person interaction; Participants will interact with the speech-language pathologist in-person at the speech pathologist's office

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Caregiver Quality of Life	Scale of Quality of Life of Care-givers	Change from baseline after 6 months of treatment
Depression: Caregiver Geriatric Depression Scale	Geriatric Depression Scale	Change from baseline after 6 months of treatment
Change in Patient with PD Ratings of Communication Competence	Communicative Participation Item Bank-Short Form	Change from baseline after 6 months of treatment
Change in Patient with PD quality of life	Parkinson's Disease Questionnaire-39	Change from baseline after 6 months of treatment
Attractiveness of the telehealth platform.	Survey requesting SLP data regarding patients seen during the study period and adoption of the telepractice model by patients	At monthly intervals during the study period (6 months for each patient)
Travel cost burden - in-person group	Survey requesting Patient/caregiver travel distances and durations	At monthly intervals during the study period (6 months for each patient)
Impact of treatment on time - telemedicine group	Survey requesting Patient and caregiver reports of time spent before and after sessions preparing and setting up equipment and clearing equipment	At monthly intervals during the study period (6 months for each patient)
Treatment adherence	Usage data from the SpeechVive and patient attendance at treatment sessions	At monthly intervals during the study period (6 months for each patient)
Change in Vocal intensity level	Sound pressure level from speech samples with and without the device in place	Change from baseline after 6 months of treatment
Change in Patient with PD Depression Level	Geriatric Depression Scale Short form	Change from baseline after 6 months of treatment
Impact of Life Events for Patient with PD and Caregiver	Change in Impact of PD on life satisfaction	Change from baseline after 6 months of treatment
Change in general self-efficacy	Self-efficacy for people with disabilities scale	Change from baseline after 6 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Speech rate	Rate of speech from speech samples with and without the device in place	Change from baseline after 6 months of treatment
Change in Pausing patterns	Number and duration of silent and filled pauses from speech samples with and without the device in place	Change from baseline after 6 months of treatment
Change in Caregiver Burden	Caregiver Burden Inventory	Change from baseline after 6 months of treatment
Change in Apathy	Apathy Scale	Change in baseline after 6 months of treatment for Patient with PD and Caregiver
Change in Caregiver Ratings Patient's of Communication Competence	Communicative Participation Item Bank-Short Form	Change in baseline after 6 months of treatment
Change in Patient with PD Participation in Social Activities	Quality of Life in Neurological Disorders (Neuro-QOL)	Change in baseline after 6 months of treatment
Change in Patient with PD Participation in Social Activities	Ability to Participate in Social Roles and Activities-Short Form	Change in baseline after 6 months of treatment
Change in Patient with PD Perceived Autonomy	7-item Autonomy Subscale of the Basic Psychological Needs Scale	Change in baseline after 6 months of treatment
Patient with PD satisfaction - telemedicine group	Survey requesting ratings of satisfaction with the telemedicine application and treatment process	At the end of the study period (after 6 months)
Caregiver satisfaction - telemedicine group	Survey requesting ratings of satisfaction with the telemedicine application and treatment process	At the end of the study period (after 6 months)
Patient with PD satisfaction - in person group	Survey requesting ratings of satisfaction with the in-person treatment process	At the end of the study period (after 6 months)
Caregiver satisfaction - in person group	Survey requesting ratings of satisfaction with the in-person treatment process	At the end of the study period (after 6 months)

Collaborators and Investigators

• Sponsor: SpeechVive, Inc
• Collaborators: Purdue University

Publications and helpful links

General Publications

• 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.

Helpful Links

• information about participating in studies through the Purdue Motor Speech Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): June 15, 2019
• Study Completion (Actual): June 15, 2019

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: speech problems
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 1R44DC014867-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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:

1. Name and institution of PI
2. Proof of institutional appointment
3. Names and roles for all individuals who will access the data for the planned analysis
4. Detailed plan for the use of the data
5. 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes