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:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT02107300
Eligibility Criteria:
Inclusion Criteria:
* Patient should be above 18 years of age.
* Patients who have been initiated on CPAP therapy after an initial diagnosis of OSAS and have developed dry mouth or have worsening of pre-existing dry mouth condition, as an effect of CPAP therapy.
* Ability to attend visits at the research site
* Patient should be able to read and/or understand and sign the consent form be willing to participate in the research study
Exclusion Criteria:
* Patients with open mouth sores at study entry.
* Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
* Patients using any other prophylactic mouthwashes.
* Patients who are pregnant and/or nursing.
* Patients becoming pregnant during the treatment period will be removed from data.
* Patients on a low sodium diet
* Patients currently on medication or treatment for xerostomia
* Patients \< 18 years of age
* Hypersensitivity to any of the following ingredients- sodium chloride, sodium phosphate, calcium chloride and sodium bicarbonate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT02107300
Study Brief:
Protocol Section:
NCT02107300