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Completed

NCT Number: NCT02107300

NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

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

Completed

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Key information

Conditions

Xerostomia Apnea Dyssomnias Mouth Diseases Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Salivary Gland Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeutraSal

Drug

NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.

placebo comparator

Drug

Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Invado Pharmaceuticals LLC

Registry information

Official study title

NeutraSal in the Management of Xerostomia in Obstructive Sleep Apnea Syndrome (OSAS) Patients Utilizing Continuous Positive Airway Pressure (CPAP) Therapy

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Apr 8, 2014
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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