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Evaluation of a Speech-to-noise Feedback Device for Treatment of Hypophonia in Parkinson's Disease

Evaluation of a Speech-to-noise Feedback Device for Treatment of Hypophonia in Parkinson's Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03648749
Enrollment
25
Registered
2018-08-27
Start date
2019-03-01
Completion date
2020-12-31
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief summary

This study will evaluate the effectiveness of a speech-to-noise feedback procedure for the treatment of hypophonia in Parkinson's disease. The procedure includes a device that records the sound intensity level of the wearer's speech and compares it to the noise level around them. The device will provide the wearer with feedback if their speech becomes too quiet for them to be heard by their listener.

Detailed description

This study will evaluate the effectiveness of a speech-to-noise feedback procedure for the treatment of hypophonia in Parkinson's disease. The procedure includes a device that records the sound intensity level of the wearer's speech and compares it to the noise level around them. The device will provide the wearer with feedback if their speech becomes too quiet for them to be heard by their listener.

Interventions

BEHAVIORALSpeech-to-noise feedback

A target speech-to-noise level is specified and feedback about achievement of the target level is provided.

Sponsors

University of Western Ontario, Canada
CollaboratorOTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A single group will be studied during no intervention (no feedback about speech) and intervention (feedback about speech) phases.

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* diagnosed with idiopathic Parkinson's disease and hypophonia by a neurologist at least 6 months prior to participation. * stabilized on antiparkinsonian medication. * good general health. * pass a 40 decibel hearing screening. * proficient enough in English to participate in speech testing.

Exclusion criteria

* history of stroke or an additional neurological or motor control disorder. * history of speech impairment that is unrelated to Parkinson's disease.

Design outcomes

Primary

MeasureTime frameDescription
Average speech-to-noise ratioSingle two-hour visit.Average speech-to-noise ratio value will be obtained over a two-hour interval.

Secondary

MeasureTime frameDescription
Percent Speech Intelligibility Score (PSIS)Single two-hour visit.PSIS is the percentage of words that can be correctly understood by a person listening (listener) to the participant's speech while they read sentences aloud. The PSIS ranges from 0% to 100%. This is a total score. Higher PSIS are considered better. The PSIS are obtained using communication partners (i.e. spouse) who listen and provide live repetitions of the spoken sentences. The spoken repetitions are transcribed by the investigators and compared to the printed reading material to calculate the percent of correctly transcribed words. The result is the PSIS referenced to a familiar listener (i.e. communication partner). The participant's spoken sentences are audio recorded and played to naïve listeners who provide written transcriptions of the participant's spoken sentences. The naïve listener transcribed sentences are compared to the printed reading material and the percent of correctly transcribed words is calculated. The result is the PSIS referenced to a naïve listener.
Ratings of Experience with the DeviceSingle two-hour visit.Participants rate their device experience with 5 visual-analogue scales (VAS) for 5 parameters. Participants see a 10cm horizontal line with end points and place a vertical line for their rating. Left is a poorer rating and right is a better rating. Parameter 1 is 'physical comfort' with left as 'uncomfortable' and right as 'comfortable'. Parameter 2 is 'visual presentation' with left as 'unacceptable' and right as 'acceptable'. Parameter 3 is 'response to feedback' with 'bothersome' (left) and 'not bothersome' (right). Parameter 4 is 'speech intensity' with 'too quiet' (left) and 'too loud' (right). Parameter 5 is 'overall preference' with 'low preference' (left) and 'high preference' (right). Vertical lines placed on the VAS are measured by hand from the left end and expressed as percent of the total VAS line. The 5 device experience parameter ratings are expressed as separate percentage VAS scores and will not be used to calculate a total score.

Countries

Canada

Contacts

Primary ContactScott Adams, PhD
sadams@uwo.ca519-661-2111
Backup ContactMandar Jog, MD
519-663-3814

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026