Parkinson DiseaseVoice-PDNCT05421832
A Novel Measurement Concept to Objectively Quantify Severity of Vocal and Speech Related Symptoms Associated With Parkinson's Disease
An observational study of Parkinson Disease, run by Northwestern University at 1 site in United States.
Trial summary
The aim of this research program is to develop and validate a smartphone app-based digital measurement concept that: Objectively quantifies the severity of Parkinson's Disease (PD) related vocal and speech symptoms; Accurately and sensitively identifies vocal and speech abnormalities associated with the prodromal… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Digital Speech Application
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2022to 30 Jun 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * PD Cohort I (n=30): PD patients assessed via the Hoehn \& Yahr (H\&Y) Scale to be in Stages 1-2 of PD (inclusive) * PD Cohort II (n = 30): PD patients assessed via the H\&Y Scale to be in Stages 3-4 of PD (inclusive) * Prodromal PD Cohort (n = 30): Patients who meet PI-defined criteria for prodromal PD, i.e., the latent phase of disease progression during which clinical PD symptoms have yet to manifest * Age \& Sex Matched Healthy Control Cohort (n = 30) - age \& sex matched healthy control subjects who have not been diagnosed with PD
Who may be able to join
- PD:
- Male or female age 30 years or older at Screening Visit.
- Diagnosis of PD as defined by MDS PD diagnostic criteria [1]
- PD severity at Screening Visit of either:
- PD Hoehn and Yahr Stage 1-2, inclusive (PD Cohort I)
- PD Hoehn and Yahr Stages 3-4, inclusive (PD Cohort II)
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- Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments.
- Able to provide informed consent.
- Prodromal PD:
- Confirmation that participant is eligible based on clinician determined predictive criteria of known risk of PD including
- Rapid eye movement sleep behavior disorder (RBD), possible, probable or definite, OR
- Hyposmia defined as less than 10th percentile on University of Pennsylvania Smell Identification Test (UPSIT), age and gender adjusted, OR
- Known genetic variants associated with PD risk, AND Confirmed eligible DAT scan.
- Male or female age 30 or older at Screening Visit.
- Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments
- Able to provide informed consent.
- Age \& Sex Matched Healthy Control:
- Male or female age 30 years or older at Screening visit.
- Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments
- Able to provide informed consent.
Who cannot join
- PD:
- Late-stage PD diagnosis (i.e., Hoehn \& Yahr Stage 5) at Screening Visit
- Symptomatic or atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).
- Current or active clinically significant neurological disorder other than PD (in the opinion of the Investigator).
- Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
- History of drug and/or alcohol abuse within the past year prior to Screening Visit.
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- Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.
- Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation.
- Prodromal PD:
- Clinical diagnosis of PD, other parkinsonism, or dementia.
- Any current or active clinically significant neurological disorder (in the opinion of the Investigator).
- Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
- Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
- History of drug and/or alcohol abuse within the past year prior to Screening Visit.
- Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.
- Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation.
- Age \& Sex Matched Healthy Control:
- First degree relative with PD (i.e., biologic parent, sibling, child).
- Any current or active clinically significant neurological disorder (in the opinion of the Investigator).
- Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
- Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
- History of drug and/or alcohol abuse within the past year prior to Screening Visit.
- Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.
- Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this research program is to develop and validate a smartphone app-based digital measurement concept that:
- Objectively quantifies the severity of Parkinson's Disease (PD) related vocal and speech symptoms;
- Accurately and sensitively identifies vocal and speech abnormalities associated with the prodromal stage of PD.
Read the detailed description
Although multiple approaches to this problem have been proposed in addition to commercially available speech analytics platforms, there is currently no established measure which incorporates the disparate aspects of affected speech to fully characterize Parkinson's symptom progression, particularly in the prodromal phase.
The measurement concept being evaluated in the present study utilizes a custom smartphone-based speech assessment tool to extract multiple hypothesis-driven acoustic features from patient speech in a real-life environment. The resultant features will be used to train a pair of supervised machine learning models to predict clinical PD symptom severity scores, and to distinguish prodromal PD patients from both healthy matched controls and PD patients in more advanced phases of disease progression.
- Conditions
- Parkinson Disease
- Being tested
- Digital Speech Application
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Speech ApplicationDevice
A custom smartphone-based speech assessment tool to extract multiple hypothesis-driven acoustic features from patient speech in a real-life environment.
| Study group | Role | What they receive |
|---|---|---|
| PD Cohort 1 | PD patients assessed via the Hoehn \& Yahr (H\&Y) Scale to be in Stages 1-2 of PD (inclusive) Receives: Device: Digital Speech Application | |
| PD Cohort 2 | PD patients assessed via the H\&Y Scale to be in Stages 3-4 of PD (inclusive) Receives: Device: Digital Speech Application | |
| Prodromal PD | Patients who meet PI-defined criteria for prodromal PD, i.e., the latent phase of disease progression during which clinical PD symptoms have yet to manifest Receives: Device: Digital Speech Application | |
| Age and Sex-matched Healthy Control | Age \& sex matched healthy control subjects who have not been diagnosed with PD Receives: Device: Digital Speech Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of digital speech assessment data recorded via smartphone assessments
- % Interpretable minutes of data per patient
Measured: 8 weeks
Quality of digital speech assessment data recorded via smartphone assessments
- % Interpretable vs. expected number of minutes of data per patient by complete days on study
Measured: 8 weeks
Usability of digital speech assessments
- SUS Usability scores by score, grade and adjective rating
Measured: 8 weeks
Content validity of digital speech assessments
- Percent of patients that score Excellent or Good for usability ratings
Measured: 8 weeks
Secondary outcomes (4)
Characterization and reliability of digital speech assessment features
- Candidate feature characterization: response distributions, and outlier analysis. Stratification of sustained phonation measures by MDS-UPDRS relevant speech items
Measured: 8 weeks
Reliability of digital speech assessment features
internal consistency and test-retest reliability
Measured: 8 weeks
Predictive performance of machine learning (ML) regression model
- Construct validity: convergent validity of each model output versus relevant MDS-UPDRS speech items and Parts I-IV total score, respectively; and versus Hoehn \& Yahr Stage
Measured: 8 weeks
Predictive performance of ML classification model
- Known group validity by cohort (including by H\&Y Stage/ MDS-UPDRS Parts I-IV total score)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start27 Sep 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Koneksa Health, Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Tanya Simuni, MD, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421832
- Sponsor's protocol ID
- STU00216902
- Acronym
- Voice-PD
- Status last verified
- Jul 2025
- First submitted
- 8 Jun 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Measurement Concept to Objectively Quantify Severity of Vocal and Speech Related Symptoms Associated With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05421832
- Acronym / sponsor ID
- Voice-PD / STU00216902
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Koneksa Health, Michael J. Fox Foundation for Parkinson's Research
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Jun 2022 (actual)
- 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.
The aim of this research program is to develop and validate a smartphone app-based digital measurement concept that:
- Objectively quantifies the severity of Parkinson's Disease (PD) related vocal and speech symptoms;
- Accurately and sensitively identifies vocal and speech abnormalities associated with the prodromal stage of PD.
Detailed description
Although multiple approaches to this problem have been proposed in addition to commercially available speech analytics platforms, there is currently no established measure which incorporates the disparate aspects of affected speech to fully characterize Parkinson's symptom progression, particularly in the prodromal phase.
The measurement concept being evaluated in the present study utilizes a custom smartphone-based speech assessment tool to extract multiple hypothesis-driven acoustic features from patient speech in a real-life environment. The resultant features will be used to train a pair of supervised machine learning models to predict clinical PD symptom severity scores, and to distinguish prodromal PD patients from both healthy matched controls and PD patients in more advanced phases of disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PD Cohort 1 | – | Device: Digital Speech ApplicationPD patients assessed via the Hoehn \& Yahr (H\&Y) Scale to be in Stages 1-2 of PD (inclusive) |
| PD Cohort 2 | – | Device: Digital Speech ApplicationPD patients assessed via the H\&Y Scale to be in Stages 3-4 of PD (inclusive) |
| Prodromal PD | – | Device: Digital Speech ApplicationPatients who meet PI-defined criteria for prodromal PD, i.e., the latent phase of disease progression during which clinical PD symptoms have yet to manifest |
| Age and Sex-matched Healthy Control | – | Device: Digital Speech ApplicationAge \& sex matched healthy control subjects who have not been diagnosed with PD |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * PD Cohort I (n=30): PD patients assessed via the Hoehn \& Yahr (H\&Y) Scale to be in Stages 1-2 of PD (inclusive) * PD Cohort II (n = 30): PD patients assessed via the H\&Y Scale to be in Stages 3-4 of PD (inclusive) * Prodromal PD Cohort (n = 30): Patients who meet PI-defined criteria for prodromal PD, i.e., the latent phase of disease progression during which clinical PD symptoms have yet to manifest * Age \& Sex Matched Healthy Control Cohort (n = 30) - age \& sex matched healthy control subjects who have not been diagnosed with PD
Key inclusion criteria (20 listed)
- Male or female age 30 years or older at Screening Visit.
- Diagnosis of PD as defined by MDS PD diagnostic criteria [1]
- PD severity at Screening Visit of either:
- Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments.
- Able to provide informed consent.
Key exclusion criteria (24 listed)
- Late-stage PD diagnosis (i.e., Hoehn \& Yahr Stage 5) at Screening Visit
- Symptomatic or atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).
- Current or active clinically significant neurological disorder other than PD (in the opinion of the Investigator).
- Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
- History of drug and/or alcohol abuse within the past year prior to Screening Visit.
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 |
|---|---|---|
| Digital Speech ApplicationA custom smartphone-based speech assessment tool to extract multiple hypothesis-driven acoustic features from patient speech in a real-life environment. | Device | Age and Sex-matched Healthy Control, PD Cohort 1, PD Cohort 2, Prodromal PD |
Primary outcome
Compliance of digital speech assessment data recorded via smartphone assessments
Time frame: 8 weeks
o % Interpretable minutes of data per patient
Quality of digital speech assessment data recorded via smartphone assessments
Time frame: 8 weeks
o % Interpretable vs. expected number of minutes of data per patient by complete days on study
Usability of digital speech assessments
Time frame: 8 weeks
o SUS Usability scores by score, grade and adjective rating
Content validity of digital speech assessments
Time frame: 8 weeks
o Percent of patients that score Excellent or Good for usability ratings
4 secondary outcomes
Characterization and reliability of digital speech assessment features
Time frame: 8 weeks
Reliability of digital speech assessment features
Time frame: 8 weeks
Predictive performance of machine learning (ML) regression model
Time frame: 8 weeks
Predictive performance of ML classification model
Time frame: 8 weeks
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 24 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Northwestern University at 1 site 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 20 inclusion and 24 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 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Compliance of digital speech assessment data recorded via smartphone assessments (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.