DysphoniaNCT04713033
Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice
An observational study of Dysphonia, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphonia
- What is being tested?
- surface electromyogram (sEMG) and flexible laryngoscopy
- Type of treatment
- Injection or infusion
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2021to 25 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
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- (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
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dysphonia
- Being tested
- surface electromyogram (sEMG), flexible laryngoscopy
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surface electromyogram (sEMG)Diagnostic test
Also called Trigno Wireless Biofeedback System
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.
flexible laryngoscopyDiagnostic test
Also called PENTAX Medical ENT Video Imaging System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: surface electromyogram (sEMG); Diagnostic Test: flexible laryngoscopy | |
| 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. Receives: Diagnostic Test: surface electromyogram (sEMG) | |
| 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. Receives: Diagnostic Test: surface electromyogram (sEMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline visit, 2 week visit, 2 months visit
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
Measured: Baseline visit, 2 week visit, 2 months visit
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.
Measured: Baseline visit, 2 week visit, 2 months visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start9 Sep 2021
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphoniaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Aaron Johnson, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713033
- Sponsor's protocol ID
- 20-01770
- Status last verified
- Apr 2025
- First submitted
- 14 Jan 2021
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice
- ClinicalTrials.gov ID
- NCT04713033
- Acronym / sponsor ID
- 20-01770
- Conditions
- Dysphonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vocally Healthy Controls | – | Diagnostic Test: surface electromyogram (sEMG), Diagnostic Test: flexible laryngoscopyPatients 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. |
| Muscle Tension Dysphonia Patients | – | Diagnostic Test: surface electromyogram (sEMG)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. |
| Unilateral Vocal Fold Paralysis Patients | – | Diagnostic Test: surface electromyogram (sEMG)Patients with unilateral vocal fold paralysis will be measured at baseline approximately 2 weeks after receiving a vocal fold medialization injection. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surface electromyogram (sEMG)Also: Trigno Wireless Biofeedback SystemA 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. | Diagnostic test | Muscle Tension Dysphonia Patients, Unilateral Vocal Fold Paralysis Patients, Vocally Healthy Controls |
| flexible laryngoscopyAlso: PENTAX Medical ENT Video Imaging SystemA 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. | Diagnostic test | Vocally Healthy Controls |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Johnson principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphonia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pitch and Loudness levels in vocal tasks (time frame: Baseline visit, 2 week visit, 2 months visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.