Trial Outcomes & Findings for OTC Mouthpiece for Snoring (NCT NCT03128307)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

604 participants

Primary outcome timeframe

Baseline and 10 Days

Results posted on

2017-12-14

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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 Study STARTED	604
Overall Study COMPLETED	570
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	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 Study Lost to Follow-up	29
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinical Trial Participants n=570 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.
Age, Continuous	48 years STANDARD_DEVIATION 11 • n=570 Participants
Sex: Female, Male Female	105 Participants n=570 Participants
Sex: Female, Male Male	465 Participants n=570 Participants
Snoring Severity Scale (1-9)	6.2 units on a scale STANDARD_DEVIATION 1.57 • n=570 Participants
How Much Does your Snoring bother YOU: VAS (1-10)	5.08 units on a scale STANDARD_DEVIATION 2.91 • n=570 Participants
How Much Does your Snoring bother YOUR PARTNER: VAS (1-10)	8.92 units on a scale STANDARD_DEVIATION 1.98 • n=570 Participants
How Frequently Do you Snore: VAS (1-10)	8.94 units on a scale STANDARD_DEVIATION 2.83 • n=570 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Clinical Trial Participants n=570 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.
Snoring Severity Scale	-4.1 units on a scale Standard Deviation 0.082

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Clinical Trial Participants n=570 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.
Visual-Analogue Scale, Self-Reported Snoring Habits How much does your snoring bother YOU?	-51.5 percent change
Visual-Analogue Scale, Self-Reported Snoring Habits How much does your snoring bother YOUR PARTNER?	-60.2 percent change
Visual-Analogue Scale, Self-Reported Snoring Habits How frequently do you snore?	-56.8 percent change

Adverse Events

Clinical Trial Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Clinical Trial Participants n=570 participants at risk 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.
Product Issues Device Detached	0.18% 1/570 • Number of events 1 • Four months

Additional Information

Jonathan Greenburg, DDS

Zyppah

Phone: (818) 414- 4817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place