NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Xerostomia

Treatments: Drug: Placebo Comparator; Drug: NeutraSal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02107300

CPAP

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

NeutraSal

Experimental group

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.

Treatment:

Drug: NeutraSal

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo Comparator