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

NCT04288804 | Unknown

• 1 other identifier: NIA0117210
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Dysphonia; Tremor; Neurological Disorder; Web-based; Neurological Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Control (healthy, non-PD participants)

An audio file made up of a voice recording of the sustained short a vowel sound, along with accelerometer data while maintaining various positions, will be collected.

Device: Smartphone microphone sensor; Device: Smartphone accelerometer sensor

PD

An audio file made up of a voice recording of the sustained short a vowel sound, along with accelerometer data while maintaining various positions, will be collected.

Device: Smartphone microphone sensor; Device: Smartphone accelerometer sensor

Interventions

Smartphone microphone sensor DEVICE

The volunteer will record themselves sustaining the short a vowel sound for 10 seconds.

Control (healthy, non-PD participants); PD

Smartphone accelerometer sensor DEVICE

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.

Control (healthy, non-PD participants); PD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects must be healthy controls, or clinically diagnosed with PD in order to participate. They also may not have another illness that causes tremor and/or dysphonia - subjects who have PD must also have PD-related dysphonia and PD-related tremor.

You may qualify if:

• Clinical diagnosis of Parkinson's Disease (PD)
• Healthy

You may not qualify if:

• 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

Sponsors & Collaborators

• Goalspal LLC: lead

Study Sites (1)

Goalspal LLC

Pleasanton, California, 94566, United States

RECRUITING

Related 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Accelerometer data, voice recording, question responses (age-group, gender, PD/non-PD)

MeSH Terms

Conditions

Parkinson Disease; Dysphonia; Tremor; Nervous System Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias

Central Study Contacts

Nitya Ayyagari

CONTACT

(925) 699-0817; admin@goalspal.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: February 26, 2020
• Primary Completion: December 26, 2023
• Study Completion: December 26, 2023
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

US (1)