NCT04829006

Brief Summary

The investigators aim at testing the efficacy of an app to measure sentence intelligibility in noise in speakers with Parkinson's disease and in healthy controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

March 24, 2021

Last Update Submit

April 4, 2022

Conditions

Keywords

intelligibilityvoice disordersdysarthria

Outcome Measures

Primary Outcomes (1)

  • Transcription scores

    Percent of words correctly transcribed

    30 minutes

Study Arms (1)

Speakers

OTHER

Participants will be recording sentences using a customized app, which is the focus of the current investigation. There is no arm per se, as the current investigation does not involve an intervention. The current investigation aims at developing and pilot testing an app.

Device: Understand Me For Life

Interventions

The aim of the current investigation is to test the efficacy of an app to measure sentence intelligibility in noise in speakers with Parkinson's disease and in healthy controls.

Speakers

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a medical diagnosis of Parkinson's disease
  • Have experienced changes in your voice (e.g., your voice has "lost its strength") and your voice is a current concern
  • Have not received individual speech therapy for the past 2 years (group therapy is ok)
  • Have a stable medication schedule
  • Have not received DBS (Deep Brain Stimulation)
  • Are a native speaker of American English

You may not qualify if:

  • If criteria above are not met
  • Healthy controls:
  • Be a native speaker of American English
  • Have no history of neurological impairment
  • Have no history of speech or language problems
  • If criteria above are not met
  • Listeners:
  • Be a native speaker of American English
  • Be between 18-55 years old
  • Have no history of speech-language-hearing problems
  • Pass a free hearing screening
  • Have received the Covid19 vaccine
  • If criteria above are not met

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Island University

Brooklyn, New York, 11201, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseVoice DisordersDysarthria

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArticulation DisordersSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral Manifestations

Study Officials

  • Gemma Moya Gale, Ph.D.

    Long Island University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, CCC-SLP

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 2, 2021

Study Start

April 1, 2021

Primary Completion

March 31, 2022

Study Completion

April 4, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations