A Novel Measurement Concept to Objectively Quantify Severity of Vocal and Speech Related Symptoms Associated With Parkinson's Disease

NCT05421832 | Completed

• 1 other identifier: STU00216902
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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 stage of PD.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• Compliance of digital speech assessment data recorded via smartphone assessments

  o % Interpretable minutes of data per patient

  8 weeks

• Quality of digital speech assessment data recorded via smartphone assessments

  o % Interpretable vs. expected number of minutes of data per patient by complete days on study

  8 weeks

• Usability of digital speech assessments

  o SUS Usability scores by score, grade and adjective rating

  8 weeks

• Content validity of digital speech assessments

  o Percent of patients that score Excellent or Good for usability ratings

  8 weeks

Secondary Outcomes (4)

• Characterization and reliability of digital speech assessment features

  8 weeks

• Reliability of digital speech assessment features

  8 weeks

• Predictive performance of machine learning (ML) regression model

  8 weeks

• Predictive performance of ML classification model

  8 weeks

Study Arms (4)

PD Cohort 1

PD patients assessed via the Hoehn \& Yahr (H\&Y) Scale to be in Stages 1-2 of PD (inclusive)

Device: Digital Speech Application

PD Cohort 2

PD patients assessed via the H\&Y Scale to be in Stages 3-4 of PD (inclusive)

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

Device: Digital Speech Application

Age and Sex-matched Healthy Control

Age \& sex matched healthy control subjects who have not been diagnosed with PD

Device: Digital Speech Application

Interventions

Digital Speech Application DEVICE

A custom smartphone-based speech assessment tool to extract multiple hypothesis-driven acoustic features from patient speech in a real-life environment.

Age and Sex-matched Healthy Control; PD Cohort 1; PD Cohort 2; Prodromal PD

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Koneksa Health: collaborator
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 16, 2022
• Study Start: September 27, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)