Overview

This trial is active, not recruiting.

Condition xerostomia
Treatments neutrasal, placebo (for neutrasal)
Sponsor Medical University of South Carolina
Collaborator Invado Pharmaceuticals LLC
Start date November 2013
End date April 2017
Trial size 32 participants
Trial identifier NCT02107300, CPAP

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
NeutraSal, dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.
neutrasal
NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.
(Placebo Comparator)
Placebo dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.
placebo (for neutrasal)
Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal

Primary Outcomes

Measure
Impact of NeutraSal on OSAS patients
time frame: 12 weeks

Secondary Outcomes

Measure
Prevention or reduction of dry mouth with NeutraSal
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 84 years old.

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

Additional Information

Official title NeutraSal in the Management of Xerostomia in Obstructive Sleep Apnea Syndrome (OSAS) Patients Utilizing Continuous Positive Airway Pressure (CPAP) Therapy
Principal investigator Chitra Lal, MD
Description Subjects diagnosed with Obstructive Sleep Apnea Syndrome (OSAS) who have started CPAP treatment and have complained of dry mouth or developed worsening of a pre-existing dry mouth as an effect of CPAP treatment will test the effectiveness of NeutraSal mouthwash in preventing or reducing his/her dry mouth perceptions and improving their compliance with CPAP.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Medical University of South Carolina.