OTC Mouthpiece for Snoring

Snoring Clinical Trial

Official title:

In-Home Study of Intraoral Device for Reducing Snoring Among Habitual Snorers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128307
• Other study ID #: Zyppah01
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2017
• Last updated: November 27, 2017
• Start date: April 7, 2017
• Est. completion date: August 10, 2017

Study information

• Verified date: November 2017
• Source: Zyppah, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Online patient registration to participate in clinical trial to test OTC mouthpiece that controls position of the tongue to reduce snoring.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: August 10, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Snoring

Intervention

Device:
• Zyppah Anti-snoring Appliance
Use of an OTC mouth guard at night to prevent snoring

Locations

Country	Name	City	State
United States	The EyeDeas Company	Lake Forest	California

Sponsors (1)

Lead Sponsor	Collaborator
Zyppah, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 10 Days
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.	Baseline and 10 Days