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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.

Tracking Information
First Submitted Date  ICMJE April 17, 2017
First Posted Date  ICMJE April 25, 2017
Results First Submitted Date  ICMJE September 30, 2017
Results First Posted Date  ICMJE December 14, 2017
Last Update Posted Date December 14, 2017
Actual Study Start Date  ICMJE April 7, 2017
Actual Primary Completion Date May 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OTC Mouthpiece for Snoring
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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  ICMJE Snoring
Intervention  ICMJE Device: Zyppah Anti-snoring Appliance
Use of an OTC mouth guard at night to prevent snoring
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2017)
604
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2017)
500
Actual Study Completion Date  ICMJE August 10, 2017
Actual Primary Completion Date May 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03128307
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Zyppah, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Zyppah, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Greenburg, DDS Zyppah, Inc.
PRS Account Zyppah, Inc.
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP