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| Name | Class |
|---|---|
| Invado Pharmaceuticals LLC | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeutraSal | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeutraSal | Drug | NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline through 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chitra Lal, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of time | Baseline and 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrasal drug related | General disorders | Non-systematic Assessment | Reported salty taste, dry mouth because of drug |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chitra Lal | Medical University of South Carolina | (843) 792-7776 | lalch@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2013 | Jul 10, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012891 | Sleep Apnea Syndromes |
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| Placebo Comparator | Drug | Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Overall Number of Baseline Participants | Count of Participants | 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
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | Baseline through 12 weeks |
|
|
|
| 0 |
| 16 |
| 7 |
| 16 |
| EG001 | 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 | 0 | 15 | 6 | 15 |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| URI | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| URI and aphthoid ulcer | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| URI and sinus infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Shingles | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Neck stiffness | General disorders | Non-systematic Assessment |
|
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| D001049 |
| Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |