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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Clinical Trial Participants 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.

Participant Flow:   Overall Study
    Clinical Trial Participants
STARTED   604 
COMPLETED   570 
NOT COMPLETED   34 
Lost to Follow-up                29 
Withdrawal by Subject                5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Clinical Trial Participants 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.

Baseline Measures
   Clinical Trial Participants 
Overall Participants Analyzed 
[Units: Participants]
 570 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed   570 
   48  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   570 
Female      105  18.4% 
Male      465  81.6% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Snoring Severity Scale (1-9) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Participants Analyzed   570 
   6.2  (1.57) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Participants Analyzed   570 
   5.08  (2.91) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Participants Analyzed   570 
   8.92  (1.98) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Participants Analyzed   570 
   8.94  (2.83) 
[1] 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.


  Outcome Measures

1.  Primary:   Snoring Severity Scale   [ Time Frame: Baseline and 10 Days ]

2.  Primary:   Visual-Analogue Scale, Self-Reported Snoring Habits   [ Time Frame: Baseline and 10 Days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: jgreenburg@outlook.com



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