SnoringPhase 3NCT03128307
OTC Mouthpiece for Snoring
A Phase 3 study testing Zyppah Anti-snoring Appliance in people with Snoring, run by Zyppah, Inc. at 1 site in United States.
Trial summary
Online patient registration to participate in clinical trial to test OTC mouthpiece that controls position of the tongue to reduce snoring. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Snoring
- What is being tested?
- Zyppah Anti-snoring Appliance
- Type of treatment
- Medical device
- How many people
- 604 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2017to 10 Aug 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Living in the United States
- Signing the Informed Consent Form
Who cannot join
- 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
Show all 10Show fewer
- Full dentures
- Braces
- Diagnosis of sleep apnea
- Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In-Home Study of Intraoral Device for Reducing Snoring Among Habitual Snorers
Online patient registration to participate in clinical trial to test OTC mouthpiece that controls position of the tongue to reduce snoring.
Read the 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.
- Conditions
- Snoring
- Being tested
- Zyppah Anti-snoring Appliance
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zyppah Anti-snoring ApplianceDevice
Use of an OTC mouth guard at night to prevent snoring
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 10 Days
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.
Measured: Baseline and 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start7 Apr 2017
- Primary completion3 May 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient serves as their own control
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zyppah, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Greenburg, DDS, Principal investigator, Zyppah, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128307
- Sponsor's protocol ID
- Zyppah01
- Status last verified
- Nov 2017
- First submitted
- 17 Apr 2017
- Last updated
- 14 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Home Study of Intraoral Device for Reducing Snoring Among Habitual Snorers
- ClinicalTrials.gov ID
- NCT03128307
- Acronym / sponsor ID
- Zyppah01
- Conditions
- Snoring
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Zyppah, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Posted 14 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Model description
- Patient serves as their own control
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age
- Living in the United States
- Signing the Informed Consent Form
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zyppah Anti-snoring ApplianceUse of an OTC mouth guard at night to prevent snoring | Device | – |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Greenburg, DDS principal investigator
Zyppah, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zyppah Anti-snoring Appliance in people with Snoring, run by Zyppah, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snoring Severity Scale (time frame: Baseline and 10 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.