Hyaluronan Formulation for Dry Mouth in Sleep Apnea Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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OSA, Dry Mouth, Xerostomia, Sleep Apnea

Intervention / Treatment
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* Device: Test Oral Spray
* Device: Placebo Oral Spray


Participation Criteria
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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 and be willing to participate in the research study Have a negative history of radiation therapy to head and neck Agree to abstain from the use of any products for xerostomia other than those provided in the study. Agree to comply with the conditions and schedule of the study. Exclusion Criteria: Subjects 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.) Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period Subjects currently on medication or treatment for dry mouth/xerostomia Subjects < 18 years of age Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate. Subjects with soft or hard tissue tumor of the oral cavity. Presence of severe gingivitis Chronic disease with concomitant oral manifestations other than xerostomia Subjects with conditions the investigator may feel will interfere with the condition under study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Oral Spray<br>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<br>* HA formulation of FDA listed ingredients<br>|
| Placebo Comparator: Placebo Oral Spray<br>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<br>* Placebo formulation without the active ingredients<br>|

What is the study measuring?
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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 |