Parkinson DiseaseNCT03648749
Evaluation of a Speech-to-noise Feedback Device for Treatment of Hypophonia in Parkinson's Disease
A study testing Speech-to-noise feedback in people with Parkinson Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Speech-to-noise feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- history of stroke or an additional neurological or motor control disorder.
- history of speech impairment that is unrelated to Parkinson's disease.
Trial locations and contacts
1 site in 1 country.
Mandar Jog, MD contact
Canada1 site
LawsonHRI
London, Ontario, N6G 1H1
Scott Adams, PhD, 519-661-2111 ext. 88941, sadams@uwo.ca
David Hill, MD, 519-646-6100 ext. 64672, info@lawsonresearch.com
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Speech-to-noise feedback
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech-to-noise feedbackBehavioural
A target speech-to-noise level is specified and feedback about achievement of the target level is provided.
| Study group | Role | What they receive |
|---|---|---|
| Speech-to-noise feedback | Experimental | A target speech-to-noise level is specified and feedback about achievement of the target level is provided Receives: Behavioral: Speech-to-noise feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average speech-to-noise ratio
Average speech-to-noise ratio value will be obtained over a two-hour interval.
Measured: Single two-hour visit.
Secondary outcomes (2)
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.
Measured: Single two-hour visit.
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.
Measured: Single two-hour visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Mar 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group will be studied during no intervention (no feedback about speech) and intervention (feedback about speech) phases.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Sponsor
- Investigators
- Scott Adams, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648749
- Sponsor's protocol ID
- LawsonHRI5264
- Other IDs
- 111861
- Status last verified
- Feb 2019
- First submitted
- 22 Aug 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Speech-to-noise Feedback Device for Treatment of Hypophonia in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03648749
- Acronym / sponsor ID
- LawsonHRI5264
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group will be studied during no intervention (no feedback about speech) and intervention (feedback about speech) phases.
| Arm | Type | Receives |
|---|---|---|
| Speech-to-noise feedback | Experimental | Behavioral: Speech-to-noise feedbackA target speech-to-noise level is specified and feedback about achievement of the target level is provided |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- history of stroke or an additional neurological or motor control disorder.
- history of speech impairment that is unrelated to Parkinson's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech-to-noise feedbackA target speech-to-noise level is specified and feedback about achievement of the target level is provided. | Behavioural | Speech-to-noise feedback |
Primary outcome
Average speech-to-noise ratio
Time frame: Single two-hour visit.
Average speech-to-noise ratio value will be obtained over a two-hour interval.
2 secondary outcomes
Percent Speech Intelligibility Score (PSIS)
Time frame: Single two-hour visit.
Ratings of Experience with the Device
Time frame: Single two-hour visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mandar Jog, MD contact
Scott Adams, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech-to-noise feedback in people with Parkinson Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott Adams, PhD (519-661-2111 ext. 88941, sadams@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average speech-to-noise ratio (time frame: Single two-hour visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.