NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy



Status:Completed
Conditions:Insomnia Sleep Studies, Other Indications, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - 84
Updated:12/13/2018
Start Date:November 2013
End Date:July 3, 2017

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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

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.

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
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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