Trial Outcomes & Findings for NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy (NCT NCT02107300)
NCT ID: NCT02107300
Last Updated: 2018-12-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2018-12-11
Participant Flow
Participant milestones
| Measure |
NeutraSal
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: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.
|
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.
Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy
Baseline characteristics by cohort
| Measure |
NeutraSal
n=16 Participants
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: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.
|
Placebo
n=15 Participants
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.
Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
n=5 Participants
|
54 years
n=7 Participants
|
53.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Overall Number of Baseline Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksTo 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.
Outcome measures
| Measure |
NeutraSal
n=16 Participants
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: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.
|
Placebo
n=15 Participants
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.
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
|
-5.09 percentage of time
Standard Deviation .27
|
11.67 percentage of time
Standard Deviation .16
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksTo 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)
Outcome measures
| Measure |
NeutraSal
n=16 Participants
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: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.
|
Placebo
n=15 Participants
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.
Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal
|
|---|---|---|
|
Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire
|
.61 score on a scale
Standard Deviation 2.78
|
.73 score on a scale
Standard Deviation 3.33
|
Adverse Events
NeutraSal
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NeutraSal
n=16 participants at risk
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: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.
|
Placebo
n=15 participants at risk
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.
Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal
|
|---|---|---|
|
General disorders
Neutrasal drug related
|
18.8%
3/16 • Number of events 3
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
0.00%
0/16
|
20.0%
3/15 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
URI and aphthoid ulcer
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
URI and sinus infection
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Shingles
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/16
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Neck stiffness
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place