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Speech-in-Noise Treatments for Hypophonia in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT04323085
Recruitment Status : Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Scott Adams, Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Speech Disorders Behavioral: Speech-in-Noise Treatment Program Behavioral: Speech-to-Noise Feedback Device Program Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Speech-in-Noise Treatments to Improve Hypophonia in Everyday Social Contexts for Individuals With Parkinson's Disease
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Speech-in-Noise Treatment Program
A behavioural speech therapy program involving 12, one-hour treatment sessions over a 4-week period
Behavioral: Speech-in-Noise Treatment Program
Speech therapy program for hypophonia.

Active Comparator: Speech-to-Noise Feedback Device Program
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
Behavioral: Speech-to-Noise Feedback Device Program
Speech Feedback device program for hypophonia.

No Intervention: Delayed Treatment
Assessments but no intervention for a period of 13 weeks.



Primary Outcome Measures :
  1. speech-to-noise ratio [ Time Frame: 7 days ]
    Average speech-to-noise ratio obtained from long-term conversation samples


Secondary Outcome Measures :
  1. communication effectiveness ratings [ Time Frame: 7 days ]
    Self-ratings of communication effectiveness using an 8-item questionnaire.

  2. communication participation ratings [ Time Frame: 7 days ]
    Self-ratings of communication participation using a 28 item questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323085


Contacts
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Contact: Scott Adams, PhD 519661-2111 ext 88941 sadams@uwo.ca
Contact: Mandar Jog, MD 5196633814 Mandar.Jog@lhsc.on.ca

Locations
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Canada, Ontario
LawsonHRI
London, Ontario, Canada, N6G 1H1
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Scott Adams Western University
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Responsible Party: Scott Adams, Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04323085    
Other Study ID Numbers: 115713
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scott Adams, Lawson Health Research Institute:
Hypophonia
Additional relevant MeSH terms:
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Parkinson Disease
Speech Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations