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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- speech-to-noise ratio [ Time Frame: 7 days ]Average speech-to-noise ratio obtained from long-term conversation samples
- communication effectiveness ratings [ Time Frame: 7 days ]Self-ratings of communication effectiveness using an 8-item questionnaire.
- communication participation ratings [ Time Frame: 7 days ]Self-ratings of communication participation using a 28 item questionnaire.
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
|Contact: Scott Adams, PhD||519661-2111 ext firstname.lastname@example.org|
|Contact: Mandar Jog, MD||5196633814||Mandar.Jog@lhsc.on.ca|
|London, Ontario, Canada, N6G 1H1|
|Principal Investigator:||Scott Adams||Western University|