NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

NeutraSal in the Management of Xerostomia in Obstructive Sleep Apnea Syndrome (OSAS) Patients Utilizing Continuous Positive Airway Pressure (CPAP) Therapy

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

Study Overview

• Status: Completed
• Conditions: Xerostomia
• Intervention / Treatment: Drug: NeutraSal; Drug: Placebo Comparator

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NeutraSal; 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.	Drug: NeutraSal; NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.
Placebo Comparator: Placebo; 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.	Drug: Placebo Comparator; Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage	To observe the impact of NeutraSal on OSAS (obstructive sleep apnoea syndrome) patients compliance to CPAP (Continuous Positive Airway Pressure) therapy compared to placebo. CPAP usage is determined by % of nights CPAP use was greater than 4 hours.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire	To assess whether the daily use of NeutraSal will prevent or reduce dry mouth perception in OSAS patients undergoing CPAP therapy. Dry Mouth perception will be measured by an Xerostomia Questionnaire which rates mouth dryness. The scale is rated from 1-10 (1 being dry as a desert and 10 is normal)	Baseline through 12 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Invado Pharmaceuticals LLC
• Investigators: Principal Investigator: Chitra Lal, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): April 10, 2015
• Study Completion (Actual): July 3, 2017

Study Registration Dates

• First Submitted: March 28, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea Syndrome
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Sleep Apnea Syndromes; Xerostomia
• Other Study ID Numbers: CPAP