Muscle Activity Analysis for Hoarseness

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Head/neck surgery, Smart implant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 months

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Aaron Johnson

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with muscle tension dysphonia or unilateral vocal cord paralysis, recommended for voice therapy or vocal fold injection medialization. Participants must be able to consent and complete assessments. Excluded are those with allergies to the device, 'smart' implants, recent head/neck surgery, open wounds near sensors, abnormal laryngeal structures, or involvement in other investigational studies.

Inclusion Criteria

Control Group: Willingness to complete all clinical/research assessments

I am over 18 years old.

I have been diagnosed with one-sided vocal cord paralysis and advised to get a vocal fold injection.

Exclusion Criteria

Experimental Group: Participation in additional clinical research studies using investigational treatments

I had surgery on my head or neck in the last 3 months.

Control Group: Participation in additional clinical research studies using investigational treatments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline sEMG measurements and vocal tasks are conducted to assess cervical-cranial muscle network activity

1 visit

1 visit (in-person)

Treatment

Participants undergo vocal loading tasks and receive interventions such as voice therapy or vocal fold medialization

2 months

2 visits (in-person)

Follow-up

Participants are monitored for changes in pitch, loudness, and phonatory effort after treatment

2 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Computational Cranial and Cervical Muscle Network

Trial Overview The study aims to develop a new diagnostic tool by measuring muscle activity in the neck and head using surface electromyogram (sEMG) and flexible laryngoscopy. It will compare typical voicing against disordered conditions before and after vocal fatigue to understand neuromuscular mechanisms better.

How Is the Trial Designed?

Group I: Vocally Healthy Controls Experimental Treatment 2 Interventions

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.

Group II: Unilateral Vocal Fold Paralysis Patients Experimental Treatment 1 Intervention

Patients with unilateral vocal fold paralysis will be measured at baseline approximately 2 weeks after receiving a vocal fold medialization injection.

Group III: Muscle Tension Dysphonia Patients Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+