Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-01-13 @ 8:23 AM
Study NCT ID:
NCT02107300
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2014-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lalch@musc.edu', 'phone': '(843) 792-7776', 'title': 'Chitra Lal', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'NeutraSal', 'description': '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.\n\nNeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.', 'otherNumAtRisk': 16, 'otherNumAffected': 7, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal', 'otherNumAtRisk': 15, 'otherNumAffected': 6, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Neutrasal drug related', 'notes': 'Reported salty taste, dry mouth because of drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'URI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'URI and aphthoid ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'URI and sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NeutraSal', 'description': '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.\n\nNeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.09', 'spread': '.27', 'groupId': 'OG000'}, {'value': '11.67', 'spread': '.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': '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.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NeutraSal', 'description': '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.\n\nNeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal'}], 'classes': [{'categories': [{'measurements': [{'value': '.61', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '.73', 'spread': '3.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 12 weeks', 'description': '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)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NeutraSal', 'description': '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.\n\nNeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.'}, {'id': 'FG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NeutraSal', 'description': '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.\n\nNeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.'}, {'id': 'BG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '80'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '37', 'upperLimit': '71'}, {'value': '53.5', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Overall Number of Baseline Participants', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-09-12', 'size': 180325, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-10T12:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-16', 'studyFirstSubmitDate': '2014-03-28', 'resultsFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-16', 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage', 'timeFrame': 'Baseline and 12 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire', 'timeFrame': 'Baseline through 12 weeks', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea Syndrome'], 'conditions': ['Xerostomia']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient should be above 18 years of age.\n* 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.\n* Ability to attend visits at the research site\n* Patient should be able to read and/or understand and sign the consent form be willing to participate in the research study\n\nExclusion Criteria:\n\n* Patients with open mouth sores at study entry.\n* Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)\n* Patients using any other prophylactic mouthwashes.\n* Patients who are pregnant and/or nursing.\n* Patients becoming pregnant during the treatment period will be removed from data.\n* Patients on a low sodium diet\n* Patients currently on medication or treatment for xerostomia\n* Patients \\< 18 years of age\n* Hypersensitivity to any of the following ingredients- sodium chloride, sodium phosphate, calcium chloride and sodium bicarbonate'}, 'identificationModule': {'nctId': 'NCT02107300', 'briefTitle': 'NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'NeutraSal in the Management of Xerostomia in Obstructive Sleep Apnea Syndrome (OSAS) Patients Utilizing Continuous Positive Airway Pressure (CPAP) Therapy', 'orgStudyIdInfo': {'id': 'CPAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NeutraSal', 'description': '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.', 'interventionNames': ['Drug: NeutraSal']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo Comparator']}], 'interventions': [{'name': 'NeutraSal', 'type': 'DRUG', 'description': 'NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.', 'armGroupLabels': ['NeutraSal']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Chitra Lal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Invado Pharmaceuticals LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}