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

Lawson Health Research Institute

Status and phase: Unknown; Phase 2

Conditions: Speech Disorders; Parkinson Disease

Treatments: Behavioral: Speech-in-Noise Treatment Program; Behavioral: Speech-to-Noise Feedback Device Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04323085

115713

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Speech-in-Noise Treatment Program

Active Comparator group

Description:

A behavioural speech therapy program involving 12, one-hour treatment sessions over a 4-week period

Treatment:

Behavioral: Speech-in-Noise Treatment Program

Speech-to-Noise Feedback Device Program

Active Comparator group

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

Treatment:

Behavioral: Speech-to-Noise Feedback Device Program

Delayed Treatment

No Intervention group

Description:

Assessments but no intervention for a period of 13 weeks.