Snoring
Conditions
Brief summary
Online patient registration to participate in clinical trial to test OTC mouthpiece that controls position of the tongue to reduce snoring.
Detailed description
Patient will complete informed consent, inclusion/exclusion criteria, sleep apnea and snoring surveys online. If patient meets all criteria for the study, patient will be provided with a treatment device for use for a 10 day treatment period. Patient will complete the trial upon providing final online surveys.
Interventions
DEVICEZyppah Anti-snoring Appliance
Use of an OTC mouth guard at night to prevent snoring
Sponsors
Zyppah, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
The data is compiled and analyzed by an outside, independent organization
Intervention model description
Patient serves as their own control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Over 18 years of age * Living in the United States * Signing the Informed Consent Form
Exclusion criteria
* Missing teeth (as the device won't be properly fitted) * Any severe breathing or respiratory disorder, such as chronic asthma, emphysema, COPD, or a similar condition * Poor dental health, such as severe gum disease, loose teeth, an abscess, mouth sores, or bleeding gums * A dental implant placed within the last three months * Diagnosed with a Temporomandibular joint condition (TMJ) * Actively experiencing any mouth or jaw pain, including clenching of the teeth, grinding, or any other physical injury to the jaw or teeth * Full dentures * Braces * Diagnosis of sleep apnea * Less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Snoring Severity Scale | 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. |
| Visual-Analogue Scale, Self-Reported Snoring Habits | 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 570 |
| Total | 570 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 29 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Clinical Trial Participants | — |
|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 11 | — |
| How Frequently Do you Snore: VAS (1-10) | 8.94 units on a scale STANDARD_DEVIATION 2.83 | — |
| How Much Does your Snoring bother YOUR PARTNER: VAS (1-10) | 8.92 units on a scale STANDARD_DEVIATION 1.98 | — |
| How Much Does your Snoring bother YOU: VAS (1-10) | 5.08 units on a scale STANDARD_DEVIATION 2.91 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 105 Participants | — |
| Sex: Female, Male Male | 465 Participants | — |
| Snoring Severity Scale (1-9) | 6.2 units on a scale STANDARD_DEVIATION 1.57 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 570 |
| other Total, other adverse events | 1 / 570 |
| serious Total, serious adverse events | 0 / 570 |
Outcome results
Primary
Snoring Severity Scale
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Trial Participants | Snoring Severity Scale | -4.1 units on a scale | Standard Deviation 0.082 |
p-value: <0.0001t-test, 2 sided
Primary
Visual-Analogue Scale, Self-Reported Snoring Habits
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinical Trial Participants | Visual-Analogue Scale, Self-Reported Snoring Habits | How much does your snoring bother YOU? | -51.5 percent change |
| Clinical Trial Participants | Visual-Analogue Scale, Self-Reported Snoring Habits | How much does your snoring bother YOUR PARTNER? | -60.2 percent change |
| Clinical Trial Participants | Visual-Analogue Scale, Self-Reported Snoring Habits | How frequently do you snore? | -56.8 percent change |
p-value: <0.0001t-test, 2 sided