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OTC Mouthpiece for Snoring

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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Double (Care Provider, Investigator);   Primary Purpose: Treatment
Condition Snoring
Intervention Device: Zyppah Anti-snoring Appliance
Enrollment 604
Recruitment Details Subjects recruited online. A total of 764 expressed interest in the trial. 143 potential subjects either opted not to participate or did not meet the inclusion/exclusion criteria.
Pre-assignment Details  
Arm/Group Title Clinical Trial Participants
Hide Arm/Group Description Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
Period Title: Overall Study
Started 604
Completed 570
Not Completed 34
Reason Not Completed
Lost to Follow-up             29
Withdrawal by Subject             5
Arm/Group Title Clinical Trial Participants
Hide Arm/Group Description Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
Overall Number of Baseline Participants 570
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 570 participants
48  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 570 participants
Female
105
  18.4%
Male
465
  81.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Snoring Severity Scale (1-9)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 570 participants
6.2  (1.57)
[1]
Measure 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.
How Much Does your Snoring bother YOU: VAS (1-10)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 570 participants
5.08  (2.91)
[1]
Measure Description: A visual-analogue scale (VAS) was used to measure how much snoring bothered the individual user. A score of '0' was not bothersome at all, while a score of '10' would indicate it is extremely bothersome.
How Much Does your Snoring bother YOUR PARTNER: VAS (1-10)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 570 participants
8.92  (1.98)
[1]
Measure Description: A visual-analogue scale (VAS) was used to measure how much snoring bothered the subject's partner (if applicable). A score of '0' was not bothersome at all, while a score of '10' would indicate it is extremely bothersome.
How Frequently Do you Snore: VAS (1-10)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 570 participants
8.94  (2.83)
[1]
Measure Description: A visual-analogue scale (VAS) was used to measure how frequently the subject snored. A score of '0' would indicate the subject never snored, while a score of '10' would indicate the subject snores every single night.
1.Primary Outcome
Title Snoring Severity Scale
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Trial Participants
Hide Arm/Group Description:
Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
Overall Number of Participants Analyzed 570
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.1  (0.082)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clinical Trial Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Assuming a priori threshold for statistical significant of p = 0.05
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Visual-Analogue Scale, Self-Reported Snoring Habits
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Trial Participants
Hide Arm/Group Description:
Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
Overall Number of Participants Analyzed 570
Measure Type: Number
Unit of Measure: percent change
How much does your snoring bother YOU? -51.5
How much does your snoring bother YOUR PARTNER? -60.2
How frequently do you snore? -56.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clinical Trial Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments a priori threshold for statistical significance of p = 0.05
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Four months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clinical Trial Participants
Hide Arm/Group Description Subjects who received the Zyppah Anti-Snoring device and were entered into the clinical study. Subjects were asked to use the device for ten consecutive nights and then fill out an online form assessing their experience with the device.
All-Cause Mortality
Clinical Trial Participants
Affected / at Risk (%)
Total   0/570 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Clinical Trial Participants
Affected / at Risk (%) # Events
Total   0/570 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clinical Trial Participants
Affected / at Risk (%) # Events
Total   1/570 (0.18%)    
Product Issues   
Device Detached * [1]  1/570 (0.18%)  1
*
Indicates events were collected by non-systematic assessment
[1]
The connection between the top tray and bottom tray was broken, causing the top and bottom trays to detach.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jonathan Greenburg, DDS
Organization: Zyppah
Phone: (818) 414- 4817
Responsible Party: Zyppah, Inc.
ClinicalTrials.gov Identifier: NCT03128307     History of Changes
Other Study ID Numbers: Zyppah01
First Submitted: April 17, 2017
First Posted: April 25, 2017
Results First Submitted: September 30, 2017
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017