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:
Zyppah, Inc.
Information provided by (Responsible Party):
Zyppah, Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: Double (Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Snoring |
Intervention |
Device: Zyppah Anti-snoring Appliance |
Enrollment | 604 |
Participant Flow
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 |
---|---|
![]() |
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 |
Baseline Characteristics
Arm/Group Title | 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. | |
Overall Number of Baseline Participants | 570 | |
![]() |
[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.
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Jonathan Greenburg, DDS |
Organization: | Zyppah |
Phone: | (818) 414- 4817 |
EMail: | jgreenburg@outlook.com |
Responsible Party: | Zyppah, Inc. |
ClinicalTrials.gov Identifier: | NCT03128307 |
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 |