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"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

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

NCT03295019•You First Services

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

VA WNY Healthcare System

Buffalo, New York, United States

Key Dates

Start Date

August 4, 2017

Primary Completion Date

June 30, 2019

Completion Date

July 31, 2019

Last Updated

January 9, 2019

Enrollment

ESTIMATED participants

Conditions

Dry MouthXerostomiaOSASleep Apnea

Interventions

Test Oral Spray

DEVICE

Placebo Oral Spray

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

Inclusion Criteria

Exclusion Criteria

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