Back to results

NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

Primary Purpose

Xerostomia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NeutraSal

Placebo Comparator

About this trial

This is an interventional prevention trial for Xerostomia focused on measuring Obstructive Sleep Apnea Syndrome

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NeutraSal

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT02107300

First Posted

March 28, 2014

Last Updated

November 16, 2018

Sponsor

Medical University of South Carolina

Collaborators

Invado Pharmaceuticals LLC

1. Study Identification

Unique Protocol Identification Number

NCT02107300

Brief Title

NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

April 10, 2015 (Actual)

Study Completion Date

July 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

Collaborators

Invado Pharmaceuticals LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Xerostomia

Keywords

Obstructive Sleep Apnea Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NeutraSal

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

NeutraSal

Intervention Description

NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.

Intervention Type

Drug

Intervention Name(s)

Placebo Comparator

Intervention Description

Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal

Primary Outcome Measure Information:

Title

Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage

Description

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire

Description

Time Frame

Baseline through 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chitra Lal, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Learn more about this trial

NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

We'll reach out to this number within 24 hrs