Back to resultsOTC Mouthpiece for Snoring
Primary Purpose
Snoring
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zyppah Anti-snoring Appliance
Sponsored by
About this trial
This is an interventional treatment trial for Snoring
Eligibility 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
Sites / Locations
- The EyeDeas Company
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03128307
Brief Title
OTC Mouthpiece for Snoring
Official Title
In-Home Study of Intraoral Device for Reducing Snoring Among Habitual Snorers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 7, 2017 (Actual)
Primary Completion Date
May 3, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zyppah, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Patient serves as their own control
Masking
Care ProviderInvestigator
Masking Description
The data is compiled and analyzed by an outside, independent organization
Allocation
N/A
Enrollment
604 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Zyppah Anti-snoring Appliance
Intervention Description
Use of an OTC mouth guard at night to prevent snoring
Primary Outcome Measure Information:
Title
Snoring Severity Scale
Description
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.
Time Frame
Baseline and 10 Days
Title
Visual-Analogue Scale, Self-Reported Snoring Habits
Description
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.
Time Frame
Baseline and 10 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Greenburg, DDS
Organizational Affiliation
Zyppah, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The EyeDeas Company
City
Lake Forest
State/Province
California
ZIP/Postal Code
92630
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
OTC Mouthpiece for Snoring
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