Status:
COMPLETED
Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Dysphonia
Eligibility:
All Genders
18-88 years
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 objectiv...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 25 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04713033
Start Date
September 9 2021
End Date
May 25 2022
Last Update
May 1 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016