OTC Mouthpiece for Snoring

• 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: Zyppah, Inc.
• Information provided by (Responsible Party): Zyppah, Inc.

Tracking Information

• First Submitted Date: April 17, 2017
• First Posted Date: April 25, 2017
• Results First Submitted Date: September 30, 2017
• Results First Posted Date: December 14, 2017
• Last Update Posted Date: December 14, 2017
• Actual Study Start Date: April 7, 2017
• Actual Primary Completion Date: May 3, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 27, 2017)

• 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.
• 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.

Original Primary Outcome Measures (submitted: April 20, 2017)

• Snoring Severity Scale [ Time Frame: 10 days ]
  Standard scale ranks 1-3 in 3 snoring categories to determine 1-9 scale
• VAS scale [ Time Frame: 10 days ]
  Quantitative assessment on 1-10 scale

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: OTC Mouthpiece for Snoring
• Official Title: In-Home Study of Intraoral Device for Reducing Snoring Among Habitual Snorers
• 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.
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

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

• Condition: Snoring

Intervention

Device: Zyppah Anti-snoring Appliance

Use of an OTC mouth guard at night to prevent snoring

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 27, 2017): 604
• Original Estimated Enrollment (submitted: April 20, 2017): 500
• Actual Study Completion Date: August 10, 2017
• Actual Primary Completion Date: May 3, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03128307
• Other Study ID Numbers: Zyppah01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Zyppah, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Zyppah, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jonathan Greenburg, DDS; Zyppah, Inc.

• PRS Account: Zyppah, Inc.
• Verification Date: November 2017