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Completed

NCT Number: NCT03128307

OTC Mouthpiece for Snoring

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

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Key information

Conditions

Snoring Pathological Conditions, Signs and Symptoms Respiratory Sounds Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The EyeDeas Company

Lake Forest, California, 92630, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zyppah Anti-snoring Appliance

Device

Use of an OTC mouth guard at night to prevent snoring

Primary outcomes

  1. Snoring Severity Scale

    Time frame: 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.

  2. Visual-Analogue Scale, Self-Reported Snoring Habits

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zyppah, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2017
Registry last updated
Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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