NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107300
• Other study ID #: CPAP
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: July 3, 2017

Study information

• Verified date: November 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 3, 2017
• Est. primary completion date: April 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Xerostomia

Intervention

Drug:
• NeutraSal
NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.
• Placebo Comparator
Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Invado Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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