N/A
N=31
NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy
Xerostomia
Bottom Line
View on ClinicalTrials.gov: NCT02107300 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage — -5.09; 11.67 percentage of time
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NeutraSal (Drug); Placebo Comparator (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage |
-5.09; 11.67 | — |
| SECONDARY Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire |
.61; .73 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02107300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.