NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy
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|ClinicalTrials.gov Identifier: NCT02107300|
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Xerostomia||Drug: NeutraSal Drug: Placebo Comparator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||NeutraSal in the Management of Xerostomia in Obstructive Sleep Apnea Syndrome (OSAS) Patients Utilizing Continuous Positive Airway Pressure (CPAP) Therapy|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||April 10, 2015|
|Actual Study Completion Date :||July 3, 2017|
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.
NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.
Placebo Comparator: Placebo
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.
Drug: Placebo Comparator
Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal
- Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage [ Time Frame: Baseline and 12 weeks ]To observe the impact of NeutraSal on OSAS (obstructive sleep apnoea syndrome) patients compliance to CPAP (Continuous Positive Airway Pressure) therapy compared to placebo. CPAP usage is determined by % of nights CPAP use was greater than 4 hours.
- Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire [ Time Frame: Baseline through 12 weeks ]To assess whether the daily use of NeutraSal will prevent or reduce dry mouth perception in OSAS patients undergoing CPAP therapy. Dry Mouth perception will be measured by an Xerostomia Questionnaire which rates mouth dryness. The scale is rated from 1-10 (1 being dry as a desert and 10 is normal)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107300
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Chitra Lal, MD||Medical University of South Carolina|