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

NCT04323085 | Unknown Phase 2

• 1 other identifier: 115713
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Speech Disorders

Keywords

Hypophonia

Outcome Measures

Primary Outcomes (1)

• speech-to-noise ratio

  Average speech-to-noise ratio obtained from long-term conversation samples

  7 days

Secondary Outcomes (2)

• communication effectiveness ratings

  7 days

• communication participation ratings

  7 days

Study Arms (3)

Speech-in-Noise Treatment Program

ACTIVE COMPARATOR

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

Behavioral: Speech-in-Noise Treatment Program

Speech-to-Noise Feedback Device Program

ACTIVE COMPARATOR

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

Delayed Treatment

NO INTERVENTION

Assessments but no intervention for a period of 13 weeks.

Interventions

Speech-in-Noise Treatment Program BEHAVIORAL

Speech therapy program for hypophonia.

Speech-in-Noise Treatment Program

Speech-to-Noise Feedback Device Program BEHAVIORAL

Speech Feedback device program for hypophonia.

Speech-to-Noise Feedback Device Program

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with idiopathic PD and hypophonia by a neurologist at least 6 months prior to participation.
• Stabilized on antiparkinsonian medication.
• Good general health.
• years old.
• Pass a 50 dB hearing screening and cognitive screening (\>20/30 on MOCA).
• Proficient enough in English to participate in speech testing.

You may not qualify if:

• History of stroke or an additional neurological or motor control disorder.
• History of speech impairment that is unrelated to PD.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

LawsonHRI

London, Ontario, N6G 1H1, Canada

Location

MeSH Terms

Conditions

Parkinson Disease; Speech Disorders

Condition Hierarchy (Ancestors)

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott Adams

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Adams, PhD

CONTACT

519661-2111; sadams@uwo.ca

Mandar Jog, MD

CONTACT

5196633814; Mandar.Jog@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: July 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)