Development of Software to Provide the SpeechVive Device Via the Internet

Parkinson Disease Clinical Trial

Official title:

Development of a Telehealth Platform for Treatment With the SpeechVive Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744911
• Other study ID #: 1R44DC014867-01A1
• Status: Completed
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: June 15, 2019

Study information

• Verified date: September 2019
• Source: SpeechVive, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: June 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• In person interaction
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office

Locations

Country	Name	City	State
United States	SpeechVive, Inc	Lafayette	Indiana
United States	Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
SpeechVive, Inc	Purdue University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Caregiver Quality of Life	Scale of Quality of Life of Care-givers	Change from baseline after 6 months of treatment
Primary	Depression: Caregiver Geriatric Depression Scale	Geriatric Depression Scale	Change from baseline after 6 months of treatment
Primary	Change in Patient with PD Ratings of Communication Competence	Communicative Participation Item Bank-Short Form	Change from baseline after 6 months of treatment
Primary	Change in Patient with PD quality of life	Parkinson's Disease Questionnaire-39	Change from baseline after 6 months of treatment
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	Change in Patient with PD Depression Level	Geriatric Depression Scale Short form	Change from baseline after 6 months of treatment
Primary	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
Primary	Change in general self-efficacy	Self-efficacy for people with disabilities scale	Change from baseline after 6 months of treatment
Secondary	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
Secondary	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
Secondary	Change in Caregiver Burden	Caregiver Burden Inventory	Change from baseline after 6 months of treatment
Secondary	Change in Apathy	Apathy Scale	Change in baseline after 6 months of treatment for Patient with PD and Caregiver
Secondary	Change in Caregiver Ratings Patient's of Communication Competence	Communicative Participation Item Bank-Short Form	Change in baseline after 6 months of treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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