NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

NCT02107300 | Completed Results

• 1 other identifier: CPAP
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Xerostomia

Keywords

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire

  Baseline through 12 weeks

Study Arms (2)

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.

Drug: NeutraSal

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.

Drug: Placebo Comparator

Interventions

NeutraSal DRUG

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

NeutraSal

Placebo Comparator DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Invado Pharmaceuticals LLC: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Xerostomia; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chitra Lal
• Organization: Medical University of South Carolina

lalch@musc.edu

(843) 792-7776

Study Officials

• Chitra Lal, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 8, 2014
• Study Start: November 1, 2013
• Primary Completion: April 10, 2015
• Study Completion: July 3, 2017
• Last Updated: December 11, 2018
• Results First Posted: December 11, 2018

Record last verified: 2018-11

Locations

US (1)