OTC Mouthpiece for Snoring

NCT03128307 | Completed Phase 3 Results FDA Device

• 1 other identifier: Zyppah01
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Snoring

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Zyppah Anti-snoring Appliance DEVICE

Use of an OTC mouth guard at night to prevent snoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Living in the United States
• Signing the Informed Consent Form

You may not qualify if:

• 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

Sponsors & Collaborators

• Zyppah, Inc.: lead

Study Sites (1)

The EyeDeas Company

Lake Forest, California, 92630, United States

Location

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jonathan Greenburg, DDS
• Organization: Zyppah

jgreenburg@outlook.com

(818) 414- 4817

Study Officials

• Jonathan Greenburg, DDS

  Zyppah, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The data is compiled and analyzed by an outside, independent organization
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patient serves as their own control

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 25, 2017
• Study Start: April 7, 2017
• Primary Completion: May 3, 2017
• Study Completion: August 10, 2017
• Last Updated: December 14, 2017
• Results First Posted: December 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)