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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03648749
• Other study ID #: LawsonHRI5264
• Secondary ID: 111861
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2019
• Source: Lawson Health Research Institute
• Contact: Scott Adams, PhD
• Phone: 519-661-2111
• Email: sadams[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Canada	LawsonHRI	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average speech-to-noise ratio	Average speech-to-noise ratio value will be obtained over a two-hour interval.	Single two-hour visit.
Secondary	Percent Speech Intelligibility Score (PSIS)	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.	Single two-hour visit.
Secondary	Ratings of Experience with the Device	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.	Single two-hour visit.