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Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

Primary Purpose

Dysphonia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
surface electromyogram (sEMG)
flexible laryngoscopy
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dysphonia

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Experimental Group

  • Age >18 years;
  • Patient cohorts diagnosed with muscle tension dysphonia with a recommended treatment of voice therapy.
  • Patient cohorts diagnosed with unilateral vocal cord paralysis with a recommended treatment of vocal fold injection medialization.
  • Willingness to complete all clinical/research assessments
  • Ability to give informed consent

(Control Group)

  • Age >18 years;
  • Absence of any organic vocal lesion as determined on flexible laryngoscopy.
  • Willingness to complete all clinical/research assessments
  • Ability to give informed consent

Exclusion Criteria:

Experimental Group:

  • Any contraindication for wearing the device, such as a known or reported (at any time including during the study):
  • allergy;
  • history of head and neck surgery in the past 3 months;
  • presence of open wound or/and ulcer in close proximity to sEMG sensors;
  • 'smart' implant with a microcontroller (such as a pain pump or nerve stimulator);
  • participation in additional clinical research studies using investigational treatments.

Control group:

  • Any contraindication for wearing the device, such as a known or reported (at any time including during the study) allergy;
  • Abnormal laryngeal structure and function as determined via laryngeal endoscopic exam;
  • History of head and neck surgery in the past 3 months;
  • Presence of open wound or/and ulcer in close proximity to sEMG sensors;
  • 'Smart' implant with a microcontroller (such as a pain pump or nerve stimulator);
  • Participation in additional clinical research studies using investigational treatments.

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Experiment 1

Experiment 2

Experiment 3

Arm Description

Experiment 1 (Aim 1) will utilize a 16-channel sEMG array to characterize cervical-cranial muscle activity networks in typical speakers at baseline and after a vocal loading task. Flexible laryngoscopy will be performed to exclude any existing pathology and confirm eligibility in the healthy control group. Aim 2 will quantify how cervical muscle networks are perturbed in patients with two different types of dysphonia and examine if standard-of-care treatment restores cervical-cranial muscle networks to more typical states.

In Experiment 2 (Aim 2), the study will measure muscle networks in patients with muscle tension dysphonia before and after a course of voice therapy. Patients with muscle tension dysphonia represent an intact but potentially maladaptive network.

In Experiment 3 (Aim 2), the study will measure patients with unilateral vocal old paralysis, representing a neurologically impaired network, before and after a vocal fold medialization procedure.

Outcomes

Primary Outcome Measures

Change in Pitch and Loudness levels in vocal tasks
Both at baseline and after a vocal loading task, muscle network activity using sEMG will be measured in a variety of vocal tasks outlined above in Table 1 to explore the muscle network across different vocal demands and pitch and loudness levels. The pitch and loudness of each task produced at baseline by each participant will be calculated, and visual feedback will be provided to participants using the Real-Time Pitch module of the Computerized Speech Lab (Pentax, Montvale, NJ) to help them reproduce similar pitch and loudness levels during post-loading recordings.
Change in Vocal loading task
After baseline sEMG measurements, vocal fatigue will be induced using a vocal loading task of reading in the presence of 70-dB background noise, as described in Sundarrajan 51 The duration of reading that induces self-perceived vocal fatigue varies among vocally-healthy individuals.52 Therefore, we will use the CR10 Physical Exertion Scale adapted for vocal effort to have participants rate their self-perceived participant reported
Change in Phonatory Effort (PPE)
Phonatory Effort (PPE) while reading the first section of "The Rainbow Passage" at up to four time points during the load task. The vocal loading task will end after participants report an increase of at least 2 points in PPE.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2021
Last Updated
July 5, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT04713033
Brief Title
Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice
Official Title
Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The long-term goal is to transform the diagnosis and treatment of dysphonia by elucidating cervical and cranial neuromuscular mechanisms underlying typical and disordered voicing. The overall objective of this application is to propose and evaluate a novel objective spectrotemporal diagnostic tool measuring functional cervical-cranial muscle network activity in typical and disordered speakers.The purpose of this study is to improve our understanding of how the vocal tract and the muscles of the larynx and the head work at baseline and after vocal fatigue.
Detailed Description
Three experiments will be conducted over the 2-year award period. Experiment 1 (Aim 1) will utilize a 16-channel EMG array to characterize cervical-cranial muscle activity networks in typical speakers at baseline and after a vocal loading task. Aim 2 will quantify how cervical muscle networks are perturbed in patients with two different types of dysphonia and examine if standard-of-care treatment restores cervical-cranial muscle networks to more typical states. In Experiment 2 (Aim 2), we will measure muscle networks in patients with muscle tension dysphonia before and after a course of voice therapy. Patients with muscle tension dysphonia represent an intact butpotentially maladaptive network. In Experiment 3 (Aim 2), we will measure patients with unilateral vocal fold paralysis, representing a neurologically impaired network, before and after a vocal fold injection medialization procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphonia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment 1
Arm Type
Experimental
Arm Description
Experiment 1 (Aim 1) will utilize a 16-channel sEMG array to characterize cervical-cranial muscle activity networks in typical speakers at baseline and after a vocal loading task. Flexible laryngoscopy will be performed to exclude any existing pathology and confirm eligibility in the healthy control group. Aim 2 will quantify how cervical muscle networks are perturbed in patients with two different types of dysphonia and examine if standard-of-care treatment restores cervical-cranial muscle networks to more typical states.
Arm Title
Experiment 2
Arm Type
Experimental
Arm Description
In Experiment 2 (Aim 2), the study will measure muscle networks in patients with muscle tension dysphonia before and after a course of voice therapy. Patients with muscle tension dysphonia represent an intact but potentially maladaptive network.
Arm Title
Experiment 3
Arm Type
Experimental
Arm Description
In Experiment 3 (Aim 2), the study will measure patients with unilateral vocal old paralysis, representing a neurologically impaired network, before and after a vocal fold medialization procedure.
Intervention Type
Diagnostic Test
Intervention Name(s)
surface electromyogram (sEMG)
Other Intervention Name(s)
Trigno Wireless Biofeedback System
Intervention Description
A device that measures electrical signals from your skin will be connected to those stickers and will make a graph that is characteristic to your vocal function.
Intervention Type
Diagnostic Test
Intervention Name(s)
flexible laryngoscopy
Other Intervention Name(s)
PENTAX Medical ENT Video Imaging System
Intervention Description
A device that examines the throat and nasal passages. The flexible laryngoscope or "scope" consists of an eyepiece and a fiber-optic light enclosed in a thin, flexible tube. The scope looks like a strand of black spaghetti with a tiny light on the end of it. The scope is inserted through the nose, and can be moved around to help the doctor see all areas of the nasal passages and throat.
Primary Outcome Measure Information:
Title
Change in Pitch and Loudness levels in vocal tasks
Description
Both at baseline and after a vocal loading task, muscle network activity using sEMG will be measured in a variety of vocal tasks outlined above in Table 1 to explore the muscle network across different vocal demands and pitch and loudness levels. The pitch and loudness of each task produced at baseline by each participant will be calculated, and visual feedback will be provided to participants using the Real-Time Pitch module of the Computerized Speech Lab (Pentax, Montvale, NJ) to help them reproduce similar pitch and loudness levels during post-loading recordings.
Time Frame
Baseline visit, 2 week visit, 2 months visit
Title
Change in Vocal loading task
Description
After baseline sEMG measurements, vocal fatigue will be induced using a vocal loading task of reading in the presence of 70-dB background noise, as described in Sundarrajan 51 The duration of reading that induces self-perceived vocal fatigue varies among vocally-healthy individuals.52 Therefore, we will use the CR10 Physical Exertion Scale adapted for vocal effort to have participants rate their self-perceived participant reported
Time Frame
Baseline visit, 2 week visit, 2 months visit
Title
Change in Phonatory Effort (PPE)
Description
Phonatory Effort (PPE) while reading the first section of "The Rainbow Passage" at up to four time points during the load task. The vocal loading task will end after participants report an increase of at least 2 points in PPE.
Time Frame
Baseline visit, 2 week visit, 2 months visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Experimental Group Age >18 years; Patient cohorts diagnosed with muscle tension dysphonia with a recommended treatment of voice therapy. Patient cohorts diagnosed with unilateral vocal cord paralysis with a recommended treatment of vocal fold injection medialization. Willingness to complete all clinical/research assessments Ability to give informed consent (Control Group) Age >18 years; Absence of any organic vocal lesion as determined on flexible laryngoscopy. Willingness to complete all clinical/research assessments Ability to give informed consent Exclusion Criteria: Experimental Group: Any contraindication for wearing the device, such as a known or reported (at any time including during the study): allergy; history of head and neck surgery in the past 3 months; presence of open wound or/and ulcer in close proximity to sEMG sensors; 'smart' implant with a microcontroller (such as a pain pump or nerve stimulator); participation in additional clinical research studies using investigational treatments. Control group: Any contraindication for wearing the device, such as a known or reported (at any time including during the study) allergy; Abnormal laryngeal structure and function as determined via laryngeal endoscopic exam; History of head and neck surgery in the past 3 months; Presence of open wound or/and ulcer in close proximity to sEMG sensors; 'Smart' implant with a microcontroller (such as a pain pump or nerve stimulator); Participation in additional clinical research studies using investigational treatments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Johnson
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data Upon reasonable request. Requests should be directed to achlae01@nyu.edu. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

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