OTC Mouthpiece for Snoring

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

Participant Flow

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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
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

Baseline Characteristics

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Arm/Group Title		Clinical Trial Participants
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
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.

Outcome Measures

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1. Primary Outcome

Title	Snoring Severity Scale
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clinical Trial Participants
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clinical Trial Participants
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

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]

Adverse Events

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Time Frame	Four months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Clinical Trial Participants
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%)
Serious Adverse Events
	Clinical Trial Participants
	Affected / at Risk (%)	# Events
Total	0/570 (0.00%)
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.

Limitations and Caveats

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[Not Specified]

More Information

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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

EMail: 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