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NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

NCT ID: NCT02107300

Last Updated: 2018-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-07-03

Brief Summary

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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

Detailed Description

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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.

Conditions

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Xerostomia

Keywords

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

NeutraSal

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

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

Interventions

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NeutraSal

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

Intervention Type DRUG

Placebo Comparator

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Invado Pharmaceuticals LLC

INDUSTRY

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chitra Lal, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CPAP

Identifier Type: -

Identifier Source: org_study_id