Overview

NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

Status:
Completed
Trial end date:
2017-07-03
Target enrollment:
0
Participant gender:
All
Summary
To assess whether the daily use of NeutraSal will prevent or reduce dry mouth in patients undergoing CPAP therapy for OSAS and improve CPAP compliance
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of South Carolina
Collaborator:
Invado Pharmaceuticals LLC
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