Clinical trial NCT03263793: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: singing
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 18
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Average speaking intensity (dB SPL)
timeFrame: 19 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Aaron Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: