- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04288804
A Study to Analyze Symptoms Prevalent in Early PD (Dysphonia, Tremor)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Nitya Ayyagari
- Phone Number: +1 (925) 699-0817
- Email: admin@goalspal.com
Study Locations
-
-
California
-
Pleasanton, California, United States, 94566
- Recruiting
- Goalspal LLC
-
Contact:
- Nitya Ayyagari
- Phone Number: +1 925-699-0817
- Email: admin@goalspal.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
The volunteer will record themselves sustaining the short a vowel sound for 10 seconds.
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.
|
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.
|
The volunteer will record themselves sustaining the short a vowel sound for 10 seconds.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
40 seconds
|
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.
|
10 seconds
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Dyskinesias
- Signs and Symptoms, Respiratory
- Laryngeal Diseases
- Voice Disorders
- Parkinson Disease
- Tremor
- Dysphonia
- Hoarseness
Other Study ID Numbers
- NIA0117210
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Smartphone microphone sensor
-
Central Denmark RegionCompletedEmergency Medical Dispatch Centre | Video Streaming | Emergency Call | Prehospital Emergency Medical ServicesDenmark
-
University Hospital, GhentCompleted
-
Advanced BionicsEnrolling by invitationEar Diseases | Hearing Loss | Hearing Disorders | Otolaryngological DiseaseUnited States
-
Sonova AGHearts for HearingCompleted
-
Ligue Pulmonaire NeuchâteloiseNot yet recruitingChronic Obstructive Pulmonary Disease | Respiratory DiseaseSwitzerland
-
Sonova AGSonova Canada Inc.Completed
-
Sonova AGCompleted
-
Children's Hospital Medical Center, CincinnatiVerizon Foundation; Luther FoundationCompleted
-
University of UtahNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Nursing... and other collaboratorsCompletedNoninvasive Ventilation | Speech IntelligibilityUnited States
-
University College, LondonGN ResoundCompletedAuditory Processing Disorder