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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03692494
Eligibility Criteria:
Inclusion Criteria:
* Individuals with glottic insufficiency.
* Adequate cognition evidenced by score of 24 or higher on the Mini-Mental State Examination (MMSE) survey to determine if the subject has the mental capacity to participate in therapy
* Completed voice combination evaluation with speech pathologists and otolaryngologist.
* Individuals 18 years of age or older
Exclusion Criteria:
* Adults unable to consent
* Non English or Spanish speakers
* Pregnant women
* Prisoners
* Individuals with significant uncontrolled chronic and progressive respiratory diseases including COPD, interstitial lung disease, and cystic fibrosis.
* Individuals with uncontrolled blood pressure.
* Individuals with significant GI disease and/or gastroesophageal surgery with the exception of well-controlled GERD.
* Individuals with a history of abdominal hernia.
* Individuals with difficulty complying due to neuropsychological dysfunction (e.g., severe depression, psychosis).
* Individuals with other neurological disorders and/or neuromuscular disease other than Parkinson's Disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03692494
Study Brief:
Protocol Section:
NCT03692494