OTC Mouthpiece for Snoring

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

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

Study Overview

• Status: Completed
• Conditions: Snoring
• Intervention / Treatment: Device: Zyppah Anti-snoring Appliance

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.

• Study Type: Interventional
• Enrollment (Actual): 604
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Lake Forest, California, United States, 92630
      • The EyeDeas Company

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zyppah, Inc.
• Investigators: Principal Investigator: Jonathan Greenburg, DDS, Zyppah, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2017
• Primary Completion (Actual): May 3, 2017
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): December 14, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring
• Other Study ID Numbers: Zyppah01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No