Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

April 28, 2025 updated by: NYU Langone Health
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

There will be four cohorts of subjects in the study:

  • Cohort one will comprise vocally healthy controls
  • Cohort two will comprise patients with Muscle Tension Dysphonia
  • Cohort three will comprise patients with unilateral vocal fold paralysis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Vocally Healthy Controls
Patients will undergo a single experiment to quantify cervical-cranial muscle network patterns during vocal tasks at baseline and after a vocally fatiguing vocal loading task (loud reading) and typical swallowing task.
Diagnostic test: surface electromyogram (sEMG)
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.
Other Names:
  • Trigno Wireless Biofeedback System
Diagnostic test: flexible laryngoscopy
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.
Other Names:
  • PENTAX Medical ENT Video Imaging System
Muscle Tension Dysphonia Patients
Patients with muscle tension dysphonia will be measured at baseline and approximately 2 months after their baseline visit following a standard course of voice therapy.
Diagnostic test: surface electromyogram (sEMG)
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.
Other Names:
  • Trigno Wireless Biofeedback System
Unilateral Vocal Fold Paralysis Patients
Patients with unilateral vocal fold paralysis will be measured at baseline approximately 2 weeks after receiving a vocal fold medialization injection.
Diagnostic test: surface electromyogram (sEMG)
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.
Other Names:
  • Trigno Wireless Biofeedback System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pitch and Loudness levels in vocal tasks
Time Frame: Baseline visit, 2 week visit, 2 months visit
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.
Baseline visit, 2 week visit, 2 months visit
Change in Vocal loading task
Time Frame: Baseline visit, 2 week visit, 2 months visit
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
Baseline visit, 2 week visit, 2 months visit
Change in Phonatory Effort (PPE)
Time Frame: Baseline visit, 2 week visit, 2 months visit
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.
Baseline visit, 2 week visit, 2 months visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aaron Johnson, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-01770

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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