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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04288804
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Goalspal LLC

Tracking Information
First Submitted Date February 26, 2020
First Posted Date February 28, 2020
Last Update Posted Date July 21, 2020
Actual Study Start Date February 26, 2020
Estimated Primary Completion Date December 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 26, 2020)
  • PD-related Tremor [ Time Frame: 40 seconds ]
    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.
  • PD-related Dysphonia [ Time Frame: 10 seconds ]
    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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Analyze Symptoms Prevalent in Early PD (Dysphonia, Tremor)
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
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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Retention:   Samples Without DNA
Description:
Accelerometer data, voice recording, question responses (age-group, gender, PD/non-PD)
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.
Condition Parkinson Disease
Intervention
  • Device: Smartphone microphone sensor
    The volunteer will record themselves sustaining the short a vowel sound for 10 seconds.
  • Device: 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.
Study Groups/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.
    Interventions:
    • 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.
    Interventions:
    • Device: Smartphone microphone sensor
    • Device: Smartphone accelerometer sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 26, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 26, 2020
Estimated Primary Completion Date December 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Nitya Ayyagari (925) 699-0817 ext +1 admin@goalspal.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04288804
Other Study ID Numbers NIA0117210
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: 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.
Responsible Party Goalspal LLC
Study Sponsor Goalspal LLC
Collaborators Not Provided
Investigators Not Provided
PRS Account Goalspal LLC
Verification Date July 2020