A Study to Analyze Symptoms Prevalent in Early PD (Dysphonia, Tremor)
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ClinicalTrials.gov Identifier: NCT04288804 |
Recruitment Status :
Recruiting
First Posted : February 28, 2020
Last Update Posted : July 21, 2020
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Tracking Information | |||||
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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 |
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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.
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. |
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | 1 Day | ||||
Biospecimen | Retention: Samples Without DNA Description: Accelerometer data, voice recording, question responses (age-group, gender, PD/non-PD)
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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 |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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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 |
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IPD Sharing Statement |
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Responsible Party | Goalspal LLC | ||||
Study Sponsor | Goalspal LLC | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Goalspal LLC | ||||
Verification Date | July 2020 |