ClinicalTrials.gg
Status unknownNCT04288804Updated Aug 3, 2022

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

An observational study in Parkinson Disease, sponsored by Goalspal LLC. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-08-03.

Sponsored by Goalspal LLC · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,649 studies in Parkinson Disease with a site in United States — 304 open to participants now, 387 under way, 7 of them phase 3. Parkinson Disease · United States.

Planned enrollment
41st of 379
1,000 · median 78
Started
2020
with 89 others
Observational
381 of 1,649
75 open now
Registered
1,047th of 1,649
by date

Among the 1,649 studies in Parkinson Disease with a site in United States, this one is the 41st largest by planned enrollment of the 379 observational ones, is one of 90 that started in 2020, is one of 381 observational ones, and was the 1,047th registered.

By phase

1,649 studies; the count open now beside each. This study's row is marked.

No phase585 · 146 open
Observationalthis study381 · 75 open
Phase 2234 · 25 open
Phase 1175 · 32 open
Phase 3126 · 2 open
Phase 475 · 11 open
Phase 1/251 · 11 open
Phase 2/319 · 2 open
Other kind3 · 0 open

By the year they started

First in 1991; this study’s year is marked. 90 started in 2020.

Size and results

Median enrollment 36 across the 1,256 interventional studies, 78 across the 379 observational. Of the 1,139 that completed or were terminated, 435 (38%) have results posted.

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02

Study 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.

Read the detailed 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.

03

Conditions studied

  • Parkinson Disease

Keywords

  • Parkinson's Disease
  • Dysphonia
  • Tremor
  • Neurological Disorder
  • Web-based
  • Neurological Disease
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • DeviceSmartphone microphone sensor

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

  • DeviceSmartphone 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 40 seconds

  2. 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.

    Time frame: 10 seconds

07

Study locations

1 of 1 sites recruiting
  • Goalspal LLC
    Pleasanton, California 94566, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — De-identified participant data may be made available to other researchers in a compiled dataset. 24 accelerometer features from each participant will be included in their entry, tagged by a GUID. Along with this, an audio file of them sustaining the short a vowel sound for 10 seconds will be a part of their entry. Finally, their status (control/PD), gender, and age-group will be included, so that statistical analyses can be made.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2020 (actual). Primary completion is estimated for Dec 2023, 46 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2020
First posted
Feb 28, 2020
StartActual
Feb 26, 2020
Primary completionEst.
Dec 26, 2023
CompletionEst.
Dec 26, 2023
Last update
Aug 3, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04288804
Lead sponsor
Goalspal LLC
Responsible party
Sponsor
First posted
Feb 28, 2020
Start date
Feb 26, 2020
Primary completion
Dec 26, 2023 (estimated)
Completion
Dec 26, 2023 (estimated)
Last update
Aug 3, 2022

Study contacts

Nitya Ayyagari
Contact
admin@goalspal.com
(925) 699-0817 ext. +1

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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