OTC Mouthpiece for Snoring

Study Overview
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Brief Summary
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Online patient registration to participate in clinical trial to test OTC mouthpiece that controls position of the tongue to reduce snoring.

Detailed Description
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Patient will complete informed consent, inclusion/exclusion criteria, sleep apnea and snoring surveys online. If patient meets all criteria for the study, patient will be provided with a treatment device for use for a 10 day treatment period. Patient will complete the trial upon providing final online surveys.

Official Title
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In-Home Study of Intraoral Device for Reducing Snoring Among Habitual Snorers

Conditions
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Snoring

Intervention / Treatment
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* Device: Zyppah Anti-snoring Appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age Living in the United States Signing the Informed Consent Form Exclusion Criteria: Missing teeth (as the device won't be properly fitted) Any severe breathing or respiratory disorder, such as chronic asthma, emphysema, COPD, or a similar condition Poor dental health, such as severe gum disease, loose teeth, an abscess, mouth sores, or bleeding gums A dental implant placed within the last three months Diagnosed with a Temporomandibular joint condition (TMJ) Actively experiencing any mouth or jaw pain, including clenching of the teeth, grinding, or any other physical injury to the jaw or teeth Full dentures Braces Diagnosis of sleep apnea Less than 18 years of age

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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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: Patient serves as their own control
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Zyppah Anti-snoring Appliance|Use of an OTC mouth guard at night to prevent snoring|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Snoring Severity Scale | The Snoring Severity Scale (SSS) is a 9-point, validated scale to measure the severity of snoring. A total of three questions are asked: 1) How often do you snore, 2) How long do you snore, and 3) How audible is your snoring. Answers for each of these questions are summed for a total SSS score. A score of '0' would indicate no snoring at all, while a score of '9' would indicate the most severe snoring as measured by the SSS. Outcome measure reported as change with use of the device over pre-trial. In this case, a negative ('-') would represent improvement in snoring symptoms, while a positive ('+') number would indicate an increase in snoring severity. | Baseline and 10 Days | 
| Visual-Analogue Scale, Self-Reported Snoring Habits | Quantitative assessment on 1-10 scale. Outcome measurement reported as a percentage change from pre-trial with use of the device. A negative ('-') percentage would indicate a reduction in snoring symptoms as measured by the VAS, while a positive percentage ('+') result would indicate an increase in the measured symptom. | Baseline and 10 Days |