High-intensity Group Vocal Exercise to Improve Laryngeal Function in Patients With Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Choral (group) singing therapy sessions
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring singing
Eligibility Criteria
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)
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Behavioral vocal training
Arm Description
12-week vocal training program will use maximum vocal function exercises targeting vocal deficits specific to Parkinson Disease.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03263793
Brief Title
High-intensity Group Vocal Exercise to Improve Laryngeal Function in Patients With Parkinson Disease
Official Title
High-intensity Group Vocal Exercise to Improve Laryngeal Function in Patients With Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
December 13, 2017 (Actual)
Study Completion Date
December 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
singing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral vocal training
Arm Type
Experimental
Arm Description
12-week vocal training program will use maximum vocal function exercises targeting vocal deficits specific to Parkinson Disease.
Intervention Type
Behavioral
Intervention Name(s)
Choral (group) singing therapy sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average speaking intensity (dB SPL)
Description
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.
Time Frame
19 Weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Johnson, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High-intensity Group Vocal Exercise to Improve Laryngeal Function in Patients With Parkinson Disease
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