NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

Not Applicable

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Placebo	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.
NeutraSal	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.

Primary Outcome Measures

Name	Time	Method
Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage	Baseline and 12 weeks	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

Name	Time	Method
Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire	Baseline through 12 weeks	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)