N/A
Completed N=31
NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy
Source: ClinicalTrials.gov NCT02107300 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage — -5.09; 11.67 percentage of time
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
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 | — |
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. Informational only — not medical advice.