A Study to Analyze Symptoms Prevalent in Early PD (Dysphonia, Tremor)

Parkinson Disease Clinical Trial

Official title:

A Study to Analyze Features of Dysphonia and Tremor in PD Patients to Aid in the Development of an Accurate Diagnostic Tool for Early-Detection of PD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04288804
• Other study ID #: NIA0117210
• Status: Recruiting
• Start date: February 26, 2020
• Est. completion date: December 26, 2023

Study information

• Verified date: August 2022
• Source: Goalspal LLC
• Contact: Nitya Ayyagari
• Phone: (925) 699-0817
• Email: admin[@]goalspal.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a web-based study that involves monitoring hallmark symptoms of Parkinson's Disease (PD), specifically dysphonia and tremor, using smartphone sensor data. The entire length of the study will only take 5 minutes, so volunteers will not have to repeatedly contribute data. The study is made up of 5 short, 10-second long activities, which include sustaining the short a vowel sound to monitor changes in vocal fundamental frequency and holding a smartphone in different positions on either side of the body to measure changes in amplitude. To be a part of this study, volunteers must have an iPhone that is running on the software iOS 13 or higher, because they will be asked to download a smartphone application from an online App Store.

Description:

Participants will be asked to complete a series of activities, as outlined below.

1. They will be asked to turn on "Do Not Disturb" and set their smartphone's volume to the maximum. This is to ensure that they can hear narrated instructions guiding them through the activities to come, and that data collection is uninterrupted.

2. Volunteers will sustain the short a vowel sound for 10 seconds. This is to analyze PD-related dysphonia.

3. Volunteers will place their smartphone in their left hand and rest it in their lap for 10 seconds. This is to analyze PD-related rest tremor on the left side of the body. (Duration: 10 seconds)

4. Volunteers will place their smartphone in their right hand and rest it in their lap for 10 seconds. This is to analyze PD-related rest tremor on the right side of the body. (Duration: 10 seconds)

5. Volunteers will hold their smartphone face-down at shoulder-level, in their left hand. This is to analyze PD-related postural tremor on the left side of the body. (Duration: 10 seconds)

6. Volunteers will hold their smartphone face-down at shoulder-level, in their right hand. This is to analyze PD-related postural tremor on the right side of the body. (Duration: 10 seconds)

Finally, participants will be asked to indicate their gender, age group, and status (whether or not they have PD), for data-labeling purposes. Please note that all data is collected anonymously and thus cannot be tracked down to a specific participant. Nevertheless, it will be encrypted and stored in a secure database, with each participant corresponding to a GUID (Global Unique Identifier), although participants will not be asked for their name. As this is not a medical study, there are no expected medical side effects, however, certain activities and questions may seem frustrating and boring.

Participants will mainly benefit from the study indirectly, as it will increase understanding of symptoms prevalent in early PD, and may contribute to the development of diagnostic tools.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 26, 2023
• Est. primary completion date: December 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Parkinson's Disease (PD)

• Healthy

Exclusion Criteria:

• Subject does not have clinical diagnosis of PD, however, has another neurological disorder/disease that manifests with symptoms of tremor or dysphonia

• Subject diagnosed with PD does not have dysphonia and tremor

Related Conditions & MeSH terms

• Dysphonia
• Hoarseness
• Parkinson Disease
• Tremor

Intervention

Device:
• Smartphone microphone sensor
The volunteer will record themselves sustaining the short a vowel sound for 10 seconds.
• Smartphone accelerometer sensor
The volunteer's smartphone's accelerometer will record accelerometer data (positions on the x, y, and z axes) while the volunteer maintains 4 positions, each for 10 seconds.

Locations

Country	Name	City	State
United States	Goalspal LLC	Pleasanton	California

Sponsors (1)

Lead Sponsor	Collaborator
Goalspal LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD-related Tremor	24 features, composed of mean absolute deviation and mean standard deviation for each axis (x, y, z), for 4 likely occurrences of tremor, will be observed by looking at the accelerometer data file of each participant.	40 seconds
Primary	PD-related Dysphonia	Features, composed of vocal fundamental frequency, and similar measures to jitter and shimmer, will be observed by looking at the mel spectrogram for the audio file of each participant.	10 seconds

External Links

•   A visual protocol of what the study entails, complete with pictures of each screen wherein a volunteer must complete a certain activity, and how to download the mobile study.