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

NCT03263793 | Completed

• 1 other identifier: 17-00323
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

singing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Behavioral vocal training

EXPERIMENTAL

12-week vocal training program will use maximum vocal function exercises targeting vocal deficits specific to Parkinson Disease.

Behavioral: Choral (group) singing therapy sessions

Interventions

Choral (group) singing therapy sessions BEHAVIORAL

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.

Behavioral vocal training

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Aaron Johnson, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 28, 2017
• Study Start: August 22, 2017
• Primary Completion: December 13, 2017
• Study Completion: December 13, 2017
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

US (1)