NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy
This trial is active, not recruiting.
|Treatments||neutrasal, placebo (for neutrasal)|
|Sponsor||Medical University of South Carolina|
|Collaborator||Invado Pharmaceuticals LLC|
|Start date||November 2013|
|End date||April 2017|
|Trial size||32 participants|
|Trial identifier||NCT02107300, CPAP|
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
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Impact of NeutraSal on OSAS patients
time frame: 12 weeks
Prevention or reduction of dry mouth with NeutraSal
time frame: 12 weeks
Male or female participants from 18 years up to 84 years old.
- 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
- 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
|Official title||NeutraSal in the Management of Xerostomia in Obstructive Sleep Apnea Syndrome (OSAS) Patients Utilizing Continuous Positive Airway Pressure (CPAP) Therapy|
|Principal investigator||Chitra Lal, MD|
|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.|
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