Xerostomia
Conditions
Keywords
Obstructive Sleep Apnea Syndrome
Brief 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
Detailed 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.
Interventions
DRUGNeutraSal
NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.
DRUGPlacebo Comparator
Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal
Sponsors
Invado Pharmaceuticals LLC
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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 | 15 |
| Total | 31 |
Baseline characteristics
| Characteristic | NeutraSal | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 53.5 years | 54 years | 53.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 15 Participants | 31 Participants |
| Overall Number of Baseline Participants | 16 Participants | 15 Participants | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 15 Participants | 31 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 16 participants | 15 participants | 31 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 16 | 6 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
Primary
Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage
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.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NeutraSal | Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage | -5.09 percentage of time | Standard Deviation 0.27 |
| Placebo | Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage | 11.67 percentage of time | Standard Deviation 0.16 |
Secondary
Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire
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)
Time frame: Baseline through 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NeutraSal | Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire | .61 score on a scale | Standard Deviation 2.78 |
| Placebo | Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire | .73 score on a scale | Standard Deviation 3.33 |