Phase 3
N=604
OTC Mouthpiece for Snoring
Snoring
Bottom Line
View on ClinicalTrials.gov: NCT03128307 ↗Enrolled (actual)
604
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Snoring Severity Scale — -4.1 units on a scale — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zyppah Anti-snoring Appliance (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zyppah, Inc.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Snoring Severity Scale |
-4.1 | < 0.0001 sig |
| PRIMARY Visual-Analogue Scale, Self-Reported Snoring Habits |
-51.5; -60.2; -56.8 | < 0.0001 sig |
Summary
Online patient registration to participate in clinical trial to test OTC mouthpiece that controls position of the tongue to reduce snoring.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03128307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.