Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT04713033
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
88 Years
Study:
NCT04713033
Study Brief:
Protocol Section:
NCT04713033