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