"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients.

During routine clinical practice, it is observed that patients with suspected obstructive sleep apnea (OSA) often reported waking up with a dry mouth during the night or in the morning. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of a proprietary formulation in comforting dry mouth in Sleep Apnea patients.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea; OSA; Xerostomia; Dry Mouth
• Intervention / Treatment: Device: Test Oral Spray; Device: Placebo Oral Spray

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215
      • Recruiting
      • VA WNY Healthcare System
      • Contact: Archana Mishra, MD; Phone Number: 716-834-9200; Email: Archana.Mishra@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient should be above 18 years of age.
2. 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.
3. Ability to attend visits at the research site
4. Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
5. Have a negative history of radiation therapy to head and neck
6. Agree to abstain from the use of any products for xerostomia other than those provided in the study.
7. Agree to comply with the conditions and schedule of the study.

Exclusion Criteria:

1. Subjects with open mouth sores at study entry.
2. Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
3. Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
4. Subjects currently on medication or treatment for dry mouth/xerostomia
5. Subjects < 18 years of age
6. Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
7. Subjects with soft or hard tissue tumor of the oral cavity.
8. Presence of severe gingivitis
9. Chronic disease with concomitant oral manifestations other than xerostomia
10. Subjects with conditions the investigator may feel will interfere with the condition under study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test Oral Spray; Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.	Device: Test Oral Spray; HA formulation of FDA listed ingredients
PLACEBO_COMPARATOR: Placebo Oral Spray; Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their placebo mouth spray, 2 times daily (morning and evening), for the 4 week duration of the study.	Device: Placebo Oral Spray; Placebo formulation without the active ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relief from dry mouth survey using questionnaires.	Evaluate patients' perception of efficacy of a new mouth spray compared to a placebo in reducing the symptoms of dry mouth in Sleep Apnea patients. Survey will be done by distributing diaries with daily, weekly and end of study questionnaires.	9 weeks

Collaborators and Investigators

• Sponsor: You First Services

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 4, 2017
• Primary Completion (ANTICIPATED): June 30, 2019
• Study Completion (ANTICIPATED): July 31, 2019

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (ACTUAL): September 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Stomatognathic Diseases; Mouth Diseases; Signs and Symptoms, Respiratory; Salivary Gland Diseases; Sleep Apnea Syndromes; Apnea; Xerostomia
• Other Study ID Numbers: LUA-102-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No