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OTC Mouthpiece for Snoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03128307
Recruitment Status : Completed
First Posted : April 25, 2017
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Zyppah, Inc.

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

Condition or disease Intervention/treatment Phase
Snoring Device: Zyppah Anti-snoring Appliance Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patient serves as their own control
Masking: Double (Care Provider, Investigator)
Masking Description: The data is compiled and analyzed by an outside, independent organization
Primary Purpose: Treatment
Official Title: In-Home Study of Intraoral Device for Reducing Snoring Among Habitual Snorers
Actual Study Start Date : April 7, 2017
Actual Primary Completion Date : May 3, 2017
Actual Study Completion Date : August 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Snoring

Arms and Interventions
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Intervention Details:
  • Device: Zyppah Anti-snoring Appliance
    Use of an OTC mouth guard at night to prevent snoring

Outcome Measures
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Primary Outcome Measures :
  1. Snoring Severity Scale [ Time Frame: 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.


  2. Visual-Analogue Scale, Self-Reported Snoring Habits [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128307


Locations
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United States, California
The EyeDeas Company
Lake Forest, California, United States, 92630
Sponsors and Collaborators
Zyppah, Inc.
Investigators
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Principal Investigator: Jonathan Greenburg, DDS Zyppah, Inc.
  Study Documents (Full-Text)

Documents provided by Zyppah, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] January 1, 2017

More Information
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Responsible Party: Zyppah, Inc.
ClinicalTrials.gov Identifier: NCT03128307    
Other Study ID Numbers: Zyppah01
First Posted: April 25, 2017    Key Record Dates
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Snoring
Respiratory Sounds
Signs and Symptoms, Respiratory