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:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT05774457
Eligibility Criteria:
Inclusion Criteria:
By self report: (1) K-12 classroom teacher with at least two years teaching experience (SA1 and SA2) or elementary school classroom teacher (SA3), between 24 and 50 yr; (2) No history of voice disorder lasting more than two weeks, and Voice Handicap Index -10 (VHI-10)63 score \< 10; (3) Lifetime non-smoker; (4) No hearing or uncorrected visual impairment; By written documentation: (5) Proof of full COVID-19 vaccination; By clinical evaluation: (6) Normal voice on days of participation, as assessed by a voice-specialized licensed SLP based on an overall severity score from the Consensus-Auditory Perceptual Evaluation of Voice (CAPE-V) \< 10.65.
Exclusion Criteria:
By self report:(7) History of vocal fold pathology or other pathology affecting voice; (8) any acute condition that may affect voice production such as coughing, nasal congestion, or temperature greater than 98.6o F (37.0o C). Note that only vocally healthy teachers are assessed at this stage, before introducing the complexities associated with voice disorders. Those complexities will be addressed in later translational work that builds on the present series. It should be noted that the research program is ultimately relevant for teachers with voice problems, but also for the working environment of currently healthy teachers as well.
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Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
24 Years
Maximum Age:
50 Years
Study:
NCT05774457
Study Brief:
Protocol Section:
NCT05774457