OTC Mouthpiece for Snoring

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

604 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-07

Study Completion Date

2017-08-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Snoring

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patient serves as their own control

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

The data is compiled and analyzed by an outside, independent organization

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zyppah Anti-snoring Appliance

Use of an OTC mouth guard at night to prevent snoring

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jonathan Greenburg, DDS

Role: PRINCIPAL_INVESTIGATOR

Zyppah, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The EyeDeas Company

Lake Forest, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Zyppah01

Identifier Type: -

Identifier Source: org_study_id