NCT02407067

Brief Summary

This study will compare two types of assistive devices for communication (a voice amplifier and a personal communication system) in individuals with a speech disorder related to Parkinson's disease. The performance of these two devices will be examined with measures of speech intelligibility and patient questionnaires and rating scales.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

March 30, 2015

Last Update Submit

August 6, 2018

Conditions

Parkinson's DiseaseDysarthria

Outcome Measures

Primary Outcomes (3)

  • Speech Intelligibility Score

    The Sentence Intelligibility Test will be used to obtain speech intelligibility scores (%) while participants are speaking and using the two communication devices during quiet and 65 decibels of multi-talker background noise. Speech intelligibility scores will be obtained from communication partners who will provide live repetitions of the participant's spoken sentences and from listener transcriptions of the participant's audio recorded spoken sentences.

    up to 5 min

  • Device Performance Rating Score

    Visual analogue scales related to physical comfort, visual presentation, sound quality, amplification power, and overall preference will be used by the participant with Parkinson's disease and the associated communication partner to evaluate the devices following the initial 30 minutes of use (treatment) and following 7 days of use (treatment).

    30 minutes and 7 days

  • Device Satisfaction Rating Score

    The Speech Amplification Satisfaction Scale and the Quebec User Evaluation of Satisfaction with Assistive Technology Scale will be used by the participant with Parkinson's disease and the associated communication partner to evaluate the devices following 7 days of use (treatment).

    7 days

Study Arms (2)

Voice Amplifier

ACTIVE COMPARATOR

Participant will be fit with a voice amplifier (ChatterVox) and it will be used during speech testing and during regular conversations over a one week period.

Device: ChatterVox

Personal Communication System

EXPERIMENTAL

Participant will be fit with a personal communication system (Easy Listener FM system) and it will be used during speech testing and during regular conversations over a one week period.

Device: Easy Listener FM system (Phonic Ear Corp.)

Interventions

ChatterVoxDEVICE

A voice amplifier will be attached to the participant and used for the treatment of low speech intensity (hypophonia) and reduced speech intelligibility in Parkinson's disease.

Also known as: Voice Amplifier
Voice Amplifier
Easy Listener FM system (Phonic Ear Corp.)DEVICE

A personal communication (FM) system will be attached to the participant and used for the treatment of low speech intensity (hypophonia) and reduced speech intelligibility in Parkinson's disease. Personal Communication System

Personal Communication System

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Parkinson's disease by a neurologist at least 6 months prior to testing • Exhibit mild to moderate signs and symptoms of Parkinson's disease and hypophonia (reduced speech intensity) • Stabilized on antiparkinsonian medication

You may not qualify if:

  • Exhibit severe signs and symptoms of Parkinson's disease • History of stroke or an additional neurological or motor control disorder • History of speech impairment that is unrelated to Parkinson's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseaseDysarthria

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesArticulation DisordersSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Scott G Adams, PhD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share