Snoring Clinical Trial
Official title:
In-Home Study of Intraoral Device for Reducing Snoring Among Habitual Snorers
Verified date | November 2017 |
Source | Zyppah, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Online patient registration to participate in clinical trial to test OTC mouthpiece that controls position of the tongue to reduce snoring.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The EyeDeas Company | Lake Forest | California |
Lead Sponsor | Collaborator |
---|---|
Zyppah, Inc. |
United States,
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 |
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