Speech-in-Noise Treatments for Hypophonia in Parkinson's Disease
Primary Purpose
Parkinson Disease, Speech Disorders
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Speech-in-Noise Treatment Program
Speech-to-Noise Feedback Device Program
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Hypophonia
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with idiopathic PD and hypophonia by a neurologist at least 6 months prior to participation.
- Stabilized on antiparkinsonian medication.
- Good general health.
- 45-85 years old.
- Pass a 50 dB hearing screening and cognitive screening (>20/30 on MOCA).
- 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 PD.
Sites / Locations
- LawsonHRI
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Speech-in-Noise Treatment Program
Speech-to-Noise Feedback Device Program
Delayed Treatment
Arm Description
A behavioural speech therapy program involving 12, one-hour treatment sessions over a 4-week period
A speech treatment program involving the use of a speech-to-noise feedback device during 12, one-hour treatment sessions over a 4-week period
Assessments but no intervention for a period of 13 weeks.
Outcomes
Primary Outcome Measures
speech-to-noise ratio
Average speech-to-noise ratio obtained from long-term conversation samples
Secondary Outcome Measures
communication effectiveness ratings
Self-ratings of communication effectiveness using an 8-item questionnaire.
communication participation ratings
Self-ratings of communication participation using a 28 item questionnaire.
Full Information
NCT ID
NCT04323085
First Posted
March 24, 2020
Last Updated
March 24, 2020
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04323085
Brief Title
Speech-in-Noise Treatments for Hypophonia in Parkinson's Disease
Official Title
Speech-in-Noise Treatments to Improve Hypophonia in Everyday Social Contexts for Individuals With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypophonia, or reduced speech intensity, is the most prevalent speech symptom in Parkinson's disease (PD) and often leads to significant difficulty communicating in most social situations. Behavioural treatments for hypophonia can be temporarily effective but many individuals fail to retain and transfer improvements beyond the context of the speech clinic. The present study will address the transfer of treatment problem using two new treatment programs. Both treatments focus on improving speech intensity during conversations in different social contexts and a wide range of background noise conditions. The Speech-in-Noise (SIN) treatment program involves training higher speech intensity during variable levels of background noise while receiving real-time intensity feedback from a speech therapist. The second treatment, the Speech-to-Noise Feedback (SNF) device treatment program, involves using a wearable SNF device to provide feedback about an ideal target speech-to-noise level in a wide range of background noise conditions. Forty individuals with PD and their communication partners (i.e. spouse) will be randomly assigned to one of the two treatment programs. To evaluate the effectiveness of the treatments, a wearable recording device will measure daily conversational speech intensity and background noise for 7 consecutive days before, 1 week after, and 12 weeks after treatment.
Detailed Description
Parkinson's disease is one of the most common neurodegenerative diseases and is associated with several disabling motor and non-motor symptoms. About 70% of individuals with PD will develop speech impairments. Hypophonia, or reduced speech intensity, is the most prevalent speech symptom and often leads to significant difficulty communicating in most social situations. Behavioural treatments for hypophonia can be temporarily effective but many individuals fail to retain and transfer improvements beyond the context of the speech clinic. These transfer difficulties may be related to cognitive and sensorimotor deficits associated with PD that inhibit the incorporation of new speech strategies into habitual speech. This transfer of treatment problem is a longstanding and major concern in the treatment of speech in PD.
The present study will address the transfer of treatment problem using two new treatment programs. Both treatments focus on improving speech intensity during conversations in different social contexts and a wide range of background noise conditions. The Speech-in-Noise (SIN) treatment program involves training higher speech intensity during variable levels of background noise while receiving real-time intensity feedback from a speech therapist in social situations inside and outside of the clinic. The second treatment, the Speech-to-Noise Feedback (SNF) device treatment program, involves using a wearable SNF device to provide feedback about an ideal target speech-to-noise level in a wide range of background noise conditions inside and outside of the speech clinic.
Forty individuals with PD and their communication partners (i.e. spouse) will be randomly assigned to one of the two treatment programs. In addition, half of the participants will be randomly assigned to a 13-week delayed treatment group and serve as both untreated controls and treated participants.
To evaluate the effectiveness of the treatments, measures of improvement in speech intensity and speech-to-noise levels will be obtained during everyday social conversations. A wearable recording device will measure daily conversational speech intensity and background noise for 7 consecutive days at three time points: before, 1 week after, and 12 weeks after treatment. The effectiveness of treatment will be also measured using two questionnaires and standard, lab-based speech assessments.
It is anticipated that the evaluation and comparison of these two novel treatment paradigms will advance our understanding of procedures that are most effective for enhancing the transfer of treatment for hypophonia into everyday social conversations in individuals with Parkinson's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Speech Disorders
Keywords
Hypophonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Speech-in-Noise Treatment Program
Arm Type
Active Comparator
Arm Description
A behavioural speech therapy program involving 12, one-hour treatment sessions over a 4-week period
Arm Title
Speech-to-Noise Feedback Device Program
Arm Type
Active Comparator
Arm Description
A speech treatment program involving the use of a speech-to-noise feedback device during 12, one-hour treatment sessions over a 4-week period
Arm Title
Delayed Treatment
Arm Type
No Intervention
Arm Description
Assessments but no intervention for a period of 13 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Speech-in-Noise Treatment Program
Intervention Description
Speech therapy program for hypophonia.
Intervention Type
Behavioral
Intervention Name(s)
Speech-to-Noise Feedback Device Program
Intervention Description
Speech Feedback device program for hypophonia.
Primary Outcome Measure Information:
Title
speech-to-noise ratio
Description
Average speech-to-noise ratio obtained from long-term conversation samples
Time Frame
7 days
Secondary Outcome Measure Information:
Title
communication effectiveness ratings
Description
Self-ratings of communication effectiveness using an 8-item questionnaire.
Time Frame
7 days
Title
communication participation ratings
Description
Self-ratings of communication participation using a 28 item questionnaire.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with idiopathic PD and hypophonia by a neurologist at least 6 months prior to participation.
Stabilized on antiparkinsonian medication.
Good general health.
45-85 years old.
Pass a 50 dB hearing screening and cognitive screening (>20/30 on MOCA).
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 PD.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Adams, PhD
Phone
519661-2111
Ext
88941
Email
sadams@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mandar Jog, MD
Phone
5196633814
Email
Mandar.Jog@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Adams
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
LawsonHRI
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 1H1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Speech-in-Noise Treatments for Hypophonia in Parkinson's Disease
We'll reach out to this number within 24 hrs