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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
Sponsor:
Collaborator:
Invado Pharmaceuticals LLC
Information provided by (Responsible Party):
Medical University of South Carolina

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

Condition or disease Intervention/treatment Phase
Xerostomia Drug: NeutraSal Drug: Placebo Comparator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: NeutraSal
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Invado Pharmaceuticals LLC
Investigators
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Principal Investigator: Chitra Lal, MD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02107300     History of Changes
Other Study ID Numbers: CPAP
First Posted: April 8, 2014    Key Record Dates
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018
Last Verified: November 2018
Keywords provided by Medical University of South Carolina:
Obstructive Sleep Apnea Syndrome
Additional relevant MeSH terms:
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Xerostomia
Mouth Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Salivary Gland Diseases
Stomatognathic Diseases