OTC Mouthpiece for Snoring

Phase 3

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Snoring Severity Scale	Baseline and 10 Days	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.
Visual-Analogue Scale, Self-Reported Snoring Habits	Baseline and 10 Days	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.

Secondary Outcome Measures