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Development of Software to Provide the SpeechVive Device Via the Internet

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ClinicalTrials.gov Identifier: NCT02744911
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Purdue University
Information provided by (Responsible Party):
SpeechVive, Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: SpeechVive device Behavioral: Telemedicine interaction Behavioral: In person interaction Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Development of a Telehealth Platform for Treatment With the SpeechVive Device
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Change in Caregiver Quality of Life [ Time Frame: Change from baseline after 6 months of treatment ]
    Scale of Quality of Life of Care-givers

  2. Depression: Caregiver Geriatric Depression Scale [ Time Frame: Change from baseline after 6 months of treatment ]
    Geriatric Depression Scale

  3. Change in Patient with PD Ratings of Communication Competence [ Time Frame: Change from baseline after 6 months of treatment ]
    Communicative Participation Item Bank-Short Form

  4. Change in Patient with PD quality of life [ Time Frame: Change from baseline after 6 months of treatment ]
    Parkinson's Disease Questionnaire-39

  5. Attractiveness of the telehealth platform. [ Time Frame: At monthly intervals during the study period (6 months for each patient) ]
    Survey requesting SLP data regarding patients seen during the study period and adoption of the telepractice model by patients

  6. Travel cost burden - in-person group [ Time Frame: At monthly intervals during the study period (6 months for each patient) ]
    Survey requesting Patient/caregiver travel distances and durations

  7. Impact of treatment on time - telemedicine group [ Time Frame: At monthly intervals during the study period (6 months for each patient) ]
    Survey requesting Patient and caregiver reports of time spent before and after sessions preparing and setting up equipment and clearing equipment

  8. Treatment adherence [ Time Frame: At monthly intervals during the study period (6 months for each patient) ]
    Usage data from the SpeechVive and patient attendance at treatment sessions

  9. Change in Vocal intensity level [ Time Frame: Change from baseline after 6 months of treatment ]
    Sound pressure level from speech samples with and without the device in place

  10. Change in Patient with PD Depression Level [ Time Frame: Change from baseline after 6 months of treatment ]
    Geriatric Depression Scale Short form

  11. Impact of Life Events for Patient with PD and Caregiver [ Time Frame: Change from baseline after 6 months of treatment ]
    Change in Impact of PD on life satisfaction

  12. Change in general self-efficacy [ Time Frame: Change from baseline after 6 months of treatment ]
    Self-efficacy for people with disabilities scale


Secondary Outcome Measures :
  1. Change in Speech rate [ Time Frame: Change from baseline after 6 months of treatment ]
    Rate of speech from speech samples with and without the device in place

  2. Change in Pausing patterns [ Time Frame: Change from baseline after 6 months of treatment ]
    Number and duration of silent and filled pauses from speech samples with and without the device in place

  3. Change in Caregiver Burden [ Time Frame: Change from baseline after 6 months of treatment ]
    Caregiver Burden Inventory

  4. Change in Apathy [ Time Frame: Change in baseline after 6 months of treatment for Patient with PD and Caregiver ]
    Apathy Scale

  5. Change in Caregiver Ratings Patient's of Communication Competence [ Time Frame: Change in baseline after 6 months of treatment ]
    Communicative Participation Item Bank-Short Form

  6. Change in Patient with PD Participation in Social Activities [ Time Frame: Change in baseline after 6 months of treatment ]
    Quality of Life in Neurological Disorders (Neuro-QOL)

  7. Change in Patient with PD Participation in Social Activities [ Time Frame: Change in baseline after 6 months of treatment ]
    Ability to Participate in Social Roles and Activities-Short Form

  8. Change in Patient with PD Perceived Autonomy [ Time Frame: Change in baseline after 6 months of treatment ]
    7-item Autonomy Subscale of the Basic Psychological Needs Scale

  9. Patient with PD satisfaction - telemedicine group [ Time Frame: At the end of the study period (after 6 months) ]
    Survey requesting ratings of satisfaction with the telemedicine application and treatment process

  10. Caregiver satisfaction - telemedicine group [ Time Frame: At the end of the study period (after 6 months) ]
    Survey requesting ratings of satisfaction with the telemedicine application and treatment process

  11. Patient with PD satisfaction - in person group [ Time Frame: At the end of the study period (after 6 months) ]
    Survey requesting ratings of satisfaction with the in-person treatment process

  12. Caregiver satisfaction - in person group [ Time Frame: At the end of the study period (after 6 months) ]
    Survey requesting ratings of satisfaction with the in-person treatment process



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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744911


Contacts
Contact: Jessica E Huber, PhD 765-494-3796 jhuber@purdue.edu
Contact: Ashleigh Lambert, MS 303-250-9190 Ashleigh@pinevalleyspeech.com

Locations
United States, Indiana
SpeechVive, Inc Recruiting
Lafayette, Indiana, United States, 47905
Contact: Ashleigh Lambert, MS    303-250-9190    Ashleigh@pinevalleyspeech.com   
Contact: Steve Mogensen, BA    612-723-7200    smogensen@speechvive.com   
Principal Investigator: Ashleigh Lambert, MS         
Sub-Investigator: Steve Mogensen, BA         
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Sandy Snyder, MS    765-494-6488    snyder33@purdue.edu   
Contact: Jessica E Huber, PhD    765-494-3796    jhuber@purdue.edu   
Principal Investigator: Jessica E Huber, PhD         
Sub-Investigator: Sandy Snyder, MS         
Sponsors and Collaborators
SpeechVive, Inc
Purdue University

Additional Information:
Publications:
Responsible Party: SpeechVive, Inc
ClinicalTrials.gov Identifier: NCT02744911     History of Changes
Other Study ID Numbers: 1R44DC014867-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by SpeechVive, Inc:
speech problems

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases