Parkinson DiseaseNCT02744911
Development of Software to Provide the SpeechVive Device Via the Internet
A study testing SpeechVive device, Telemedicine interaction and In person interaction in people with Parkinson Disease, run by SpeechVive, Inc at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- SpeechVive device, Telemedicine interaction and In person interaction
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jan 2018to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neurological diagnoses (except Parkinson's disease)
- Bilateral hearing aids (since one free ear is required for use of the SpeechVive device)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
SpeechVive, Inc
Lafayette, Indiana, 47905
Purdue University
West Lafayette, Indiana, 47907
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- SpeechVive device, Telemedicine interaction, In person interaction
- Keywords
- speech problems
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpeechVive deviceDevice
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 interactionBehavioural
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
In person interactionBehavioural
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine group | Experimental | 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. Receives: Device: SpeechVive device; Behavioral: Telemedicine interaction |
| In person group | Active comparator | 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. Receives: Device: SpeechVive device; Behavioral: In person interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Caregiver Quality of Life
Scale of Quality of Life of Care-givers
Measured: Change from baseline after 6 months of treatment
Depression: Caregiver Geriatric Depression Scale
Geriatric Depression Scale
Measured: Change from baseline after 6 months of treatment
Change in Patient with PD Ratings of Communication Competence
Communicative Participation Item Bank-Short Form
Measured: Change from baseline after 6 months of treatment
Change in Patient with PD quality of life
Parkinson's Disease Questionnaire-39
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline after 6 months of treatment
Change in Patient with PD Depression Level
Geriatric Depression Scale Short form
Measured: 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
Measured: Change from baseline after 6 months of treatment
Change in general self-efficacy
Self-efficacy for people with disabilities scale
Measured: Change from baseline after 6 months of treatment
Secondary outcomes (12)
Change in Speech rate
Rate of speech from speech samples with and without the device in place
Measured: 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
Measured: Change from baseline after 6 months of treatment
Change in Caregiver Burden
Caregiver Burden Inventory
Measured: Change from baseline after 6 months of treatment
Change in Apathy
Apathy Scale
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At the end of the study period (after 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start26 Jan 2018
- Primary completion15 Jun 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpeechVive, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744911
- Sponsor's protocol ID
- 1R44DC014867-01A1
- Status last verified
- Sep 2019
- First submitted
- 6 Apr 2016
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
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.
PubMed 24438910Huber 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.
PubMed 22846880Darling 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.
PubMed 21386044Huber 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.
PubMed 20844256Sadagopan 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.
PubMed 17266087
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Telehealth Platform for Treatment With the SpeechVive Device
- ClinicalTrials.gov ID
- NCT02744911
- Acronym / sponsor ID
- 1R44DC014867-01A1
- Conditions
- Parkinson Disease
- Keywords
- speech problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- SpeechVive, IncIndustry (pharma, biotech, devices)
- Collaborators
- Purdue University
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine group | Experimental | Device: SpeechVive device, Behavioral: Telemedicine interactionPeople 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. |
| In person group | Active comparator | Device: SpeechVive device, Behavioral: In person interactionPeople with Parkinson's disease and their caregivers obtaining treatment using the SpeechVive device in person. Also includes speech-language pathologists providing treatment in person. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Neurological diagnoses (except Parkinson's disease)
- Bilateral hearing aids (since one free ear is required for use of the SpeechVive device)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpeechVive deviceThe 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. | Device | In person group, Telemedicine group |
| Telemedicine interactionParticipants will interact with the speech-language pathologist using the telemedicine platform from their home. | Behavioural | Telemedicine group |
| In person interactionParticipants will interact with the speech-language pathologist in-person at the speech pathologist's office | Behavioural | In person group |
Primary outcome
Change in Caregiver Quality of Life
Time frame: Change from baseline after 6 months of treatment
Scale of Quality of Life of Care-givers
Depression: Caregiver Geriatric Depression Scale
Time frame: Change from baseline after 6 months of treatment
Geriatric Depression Scale
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
Change in Patient with PD quality of life
Time frame: Change from baseline after 6 months of treatment
Parkinson's Disease Questionnaire-39
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
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
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
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
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
Change in Patient with PD Depression Level
Time frame: Change from baseline after 6 months of treatment
Geriatric Depression Scale Short form
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
Change in general self-efficacy
Time frame: Change from baseline after 6 months of treatment
Self-efficacy for people with disabilities scale
12 secondary outcomes
Change in Speech rate
Time frame: Change from baseline after 6 months of treatment
Change in Pausing patterns
Time frame: Change from baseline after 6 months of treatment
Change in Caregiver Burden
Time frame: Change from baseline after 6 months of treatment
Change in Apathy
Time frame: Change in baseline after 6 months of treatment for Patient with PD and Caregiver
Change in Caregiver Ratings Patient's of Communication Competence
Time frame: Change in baseline after 6 months of treatment
Change in Patient with PD Participation in Social Activities
Time frame: Change in baseline after 6 months of treatment
Change in Patient with PD Participation in Social Activities
Time frame: Change in baseline after 6 months of treatment
Change in Patient with PD Perceived Autonomy
Time frame: Change in baseline after 6 months of treatment
Patient with PD satisfaction - telemedicine group
Time frame: At the end of the study period (after 6 months)
Caregiver satisfaction - telemedicine group
Time frame: At the end of the study period (after 6 months)
Patient with PD satisfaction - in person group
Time frame: At the end of the study period (after 6 months)
Caregiver satisfaction - in person group
Time frame: At the end of the study period (after 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Background: PubMed 24438910Stathopoulos 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.
- Background: PubMed 22846880Huber 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.
- Background: PubMed 21386044Darling 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.
- Background: PubMed 20844256Huber 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.
- Background: PubMed 17266087Sadagopan 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpeechVive device, Telemedicine interaction and In person interaction in people with Parkinson Disease, run by SpeechVive, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Caregiver Quality of Life (time frame: Change from baseline after 6 months of treatment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744911, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.