The Effect of the DryMouth Shield on Snoring

Study Overview
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Brief Summary
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To measure the effect of the DryMouth Shield on snoring.

Detailed Description
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The primary outcome of this study is to aid in the final design of the DryMouth Shield and to assess the effect of the DryMouth Shield on snoring frequency. To accomplish this we will compare the frequency of snores during 1) overnight polysomnography without using the DryMouth Shield and 2) overnight polysomnography using the DryMouth Shield. Secondary outcomes of the study will include: 1) compare the difference in the volume of snores without and with the use of the DryMouth Shield; 2) estimate the changes in apnea hypopnea index without and with the use of the DryMouth Shield; 3) describe symptoms of dry mouth without and with the use of the DryMouth Shield 4) describe symptoms of bruxism without and with the use of the dry mouth shield and 5) gather patient feedback about the user experience with the dry mouth shield.

Official Title
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The Effect of the DryMouth Shield on Snoring

Conditions
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Snoring

Intervention / Treatment
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* Device: DryMouth Shield


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: reports of snoring that disturbed a bed partner or housemate and an objective measure of snoring such as a previous home sleep study, lab based polysomnography, or smart phone application with a snoring index of at least 20% Exclusion Criteria: Patient's with a body mass index of greater than 35 kilogram/meter squared. A history of chronic lung disease with permanently impaired lung function testing. A history of cardiovascular disease including but not limited to coronary artery disease or cerebrovascular disease. Current smokers. Patient's with a comorbid sleep disorder including but not limited to severe sleep apnea with an apnea hypopnea index of 30 events per hour, nocturnal hypoxia necessitating oxygen, current positive airway pressure use or restless legs syndrome Poor nasal patency in the judgment of the investigator Use of narcotics, benzodiazepines or other respiratory suppressing medication Females who are pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Cohort non-randomized trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Snoring cohort.<br>Subjects will undergo two nights of polysomnography. The first night will be a baseline recording. The next night subjects will use the DryMouth Shield during the polysomnography. | Device: DryMouth Shield<br>* The DryMouth Shield provides an elastomeric, one-piece design with breath-actuated, one-way valves configured to create an air-tight seal between the teeth and lips, which effectively reduces oral venting and air leakage while also allowing air flow into the mouth by generating a high-volume, low resistance airflow during inhalation while sealing when the user exhales.<br>* Other names: Oral appliance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of snoring | The percentage of number of snores during the sleep period relative to the total number of breaths during the same sleep period. A snore is defined as a breath during sleep accompanied by a vibratory noise louder than 40db | One night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of snoring | The mean volume of snoring as measured by a decibel meter. | One night |