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Completed

NCT Number: NCT04713033

Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

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.

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Key information

Conditions

Dysphonia Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Voice Disorders

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

surface electromyogram (sEMG)

Diagnostic Test

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

flexible laryngoscopy

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 19, 2021
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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