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Completed

NCT Number: NCT02744911

Development of Software to Provide the SpeechVive Device Via the Internet

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SpeechVive, Inc, Lafayette, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SpeechVive device

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.

Telemedicine interaction

Behavioral

Participants will interact with the speech-language pathologist using the telemedicine platform from their home.

In person interaction

Behavioral

Participants will interact with the speech-language pathologist in-person at the speech pathologist's office

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

SpeechVive, Inc

Industry

Collaborators

  • Purdue University

Registry information

Official study title

Development of a Telehealth Platform for Treatment With the SpeechVive Device

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2016
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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