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OTC Mouthpiece for Snoring

Z

Zyppah

Status and phase

Completed
Phase 3

Conditions

Snoring

Treatments

Device: Zyppah Anti-snoring Appliance

Study type

Interventional

Funder types

Industry

Identifiers

NCT03128307
Zyppah01

Details and patient eligibility

About

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

Full 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.

Enrollment

604 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Double Blind

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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