High-intensity Group Vocal Exercise to Improve Laryngeal Function in Patients With Parkinson Disease

The overall goal of this T2 translational research project is to pilot an interdisciplinary high-intensity group singing program to improve speech and swallowing in patients with Parkinson's Disease (PD) and to explore the impact of this program on quality of life (QOL). This research has three specific aims: 1) Determine the effects of a high-intensity group vocal training program on vocal function and laryngeal structure; 2) Determine the transference of vocal training to laryngeal aspects of swallowing; 3) Determine the effect of patient-reported changes in Quality of Life (QOL) as the result of participation in a group vocal training program.

Twenty patients with Parkinson Disease will be recruited from the Fresco Institute for Parkinson's & Movement Disorders to participate in a 12-week vocal training program. The program will train participants using maximum vocal function exercises targeting vocal deficits specific to PD. Choral singing therapy sessions will be conducted once weekly with daily home practice exercises based on principles that have been successful in other intensive PD vocal exercise programs.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Choral (group) singing therapy sessions

Detailed Description

Deterioration of speech and swallowing is a hallmark of Parkinson Disease (PD). There is emerging evidence that choral singing benefits people with PD across a range of modalities. Despite the increasing popularity of "Parkinson's choirs", rigorous study of these benefits is lacking. There is a large body of evidence that intense vocal training improves speech and communication for people with PD. However, the intense training places high demands on clinical and patient resources and, due to its individualized approach, lacks the potential psycho-social benefits of a group intervention.

It is hypothesized singing training program will increase vocal loudness, range of articulation, and prosodic variation during speech. Additionally, given existing evidence for neuroplastic transference of voice-related interventions to swallowing function, laryngeal components of swallowing function will also improve post-intervention. Finally, investigators expect to see improvements in patient-reported QOL measures corresponding with improved speech and laryngeal function and/or as the result of group interaction.

All participants will complete a standardized battery of assessment pre- and post- treatment including acoustic and aerodynamic assessment of voice, dynamic magnetic resonance imaging of speech and swallowing, and videofluoroscopic evaluation of swallowing. The outcome of this work will be a rigorous understanding of how choral singing therapy can positively impact the voice, swallowing function, and quality of life for patients with PD.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed diagnosis of Stage One, Two or Three on the Hoehn and Yahr Staging of Parkinson's Disease
• Current swallowing severity of normal, mild, or moderate without aspiration
• Stable regimen of anti-PD medication for >30 days

Exclusion Criteria:

• Prior voice and/or swallowing therapy related to PD
• History of head and neck cancer
• History of oropharyngeal or laryngeal surgery
• Current or former smoker (quit < 5 years)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral vocal training; 12-week vocal training program will use maximum vocal function exercises targeting vocal deficits specific to Parkinson Disease.	Behavioral: Choral (group) singing therapy sessions; Choral (group) singing therapy sessions will be conducted once weekly and daily home practice exercises will be assigned. All vocal exercises are based on principles that have been successful in other intensive Parkinson Disease vocal exercise programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average speaking intensity (dB SPL)	Tasks: Sustained phonation of /a/ at a comfortable pitch and loudness for 4 seconds; pitch glide throughout physiologic vocal range on /a/; standardized reading passage (CAPE-V sentences); 1-minute monologue in response to an emotionally neutral question; singing a standard song.	19 Weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Aaron Johnson, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2017
• Primary Completion (Actual): December 13, 2017
• Study Completion (Actual): December 13, 2017

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: singing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 17-00323

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No