Parkinson DiseaseNCT04288804
A Study to Analyze Symptoms Prevalent in Early PD (Dysphonia, Tremor)
An observational study of Parkinson Disease, run by Goalspal LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Smartphone microphone sensor and Smartphone accelerometer sensor
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to 26 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of Parkinson's Disease (PD)
- Healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Goalspal LLC
Pleasanton, California, 94566
Nitya Ayyagari, 925-699-0817 ext. +1, admin@goalspal.com
About this study
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
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.
- 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.
- Volunteers will sustain the short a vowel sound for 10 seconds. This is to analyze PD-related dysphonia.
- 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)
- 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)
- 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)
- 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.
- Conditions
- Parkinson Disease
- Being tested
- Smartphone microphone sensor, Smartphone accelerometer sensor
- Keywords
- Parkinson's Disease, Dysphonia, Tremor, Neurological Disorder, Web-based, Neurological Disease
- Medical subject headings
- Parkinson Disease, Dysphonia, Tremor, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone microphone sensorDevice
The volunteer will record themselves sustaining the short a vowel sound for 10 seconds.
Smartphone accelerometer sensorDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Smartphone microphone sensor; Device: Smartphone accelerometer sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start26 Feb 2020
- Primary completion26 Dec 2023 (estimated)
- Study completion26 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Goalspal LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288804
- Sponsor's protocol ID
- NIA0117210
- Status last verified
- Aug 2022
- First submitted
- 26 Feb 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04288804
- Acronym / sponsor ID
- NIA0117210
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Dysphonia, Tremor, Neurological Disorder, Web-based, Neurological Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Goalspal LLCUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 26 Dec 2023 (estimated)
- Study completion
- 26 Dec 2023 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Volunteers will sustain the short a vowel sound for 10 seconds. This is to analyze PD-related dysphonia.
- 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)
- 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)
- 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)
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (healthy, non-PD participants) | – | Device: Smartphone microphone sensor, Device: Smartphone accelerometer sensorAn 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. |
| PD | – | Device: Smartphone microphone sensor, Device: Smartphone accelerometer sensorAn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Parkinson's Disease (PD)
- Healthy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone microphone sensorThe volunteer will record themselves sustaining the short a vowel sound for 10 seconds. | Device | Control (healthy, non-PD participants), PD |
| Smartphone accelerometer sensorThe 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. | Device | Control (healthy, non-PD participants), PD |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Goalspal LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitya Ayyagari ((925) 699-0817 ext. +1, admin@goalspal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD-related Tremor (time frame: 40 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.