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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT04764604
Eligibility Criteria:
Inclusion Criteria:
* Able to understand written English without the need for an interpreter,
* No diagnosed communication impairment
* Endoscopically confirmed primary ENT diagnosis of either:
1. muscle tension dysphonia (with no laryngeal abnormality),
2. Vocal fold palsy
3. Presbylaryngis.
Exclusion Criteria:
* Previous SLT input
* Any of the following possible contraindications for PEP therapy:
* Inability to tolerate increased work of breathing,
* ICP (intracranial pressure) \> 20mm Hg,
* Recent facial/oral/skull surgery or trauma,
* Oesophageal surgery,
* Untreated pneumothorax,
* Known or suspected tympanic membrane rupture/other middle ear pathology,
* Haemodynamic instability,
* Acute sinusitis,
* Epistaxis,
* Active haemoptysis,
* Nausea
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04764604
Study Brief:
Protocol Section:
NCT04764604