Loading clinical trials...

TERMINATEDNA

The Effect of the DryMouth Shield on Snoring

NCT03701165•VMS Medical Products, Inc

Summary

To measure the effect of the DryMouth Shield on snoring.

Detailed Description

The primary outcome of this study is to aid in the final design of the DryMouth Shield and to assess the effect of the DryMouth Shield on snoring frequency. To accomplish this we will compare the frequency of snores during 1) overnight polysomnography without using the DryMouth Shield and 2) overnight polysomnography using the DryMouth Shield. Secondary outcomes of the study will include: 1) compare the difference in the volume of snores without and with the use of the DryMouth Shield; 2) estimate the changes in apnea hypopnea index without and with the use of the DryMouth Shield; 3) describe symptoms of dry mouth without and with the use of the DryMouth Shield 4) describe symptoms of bruxism without and with the use of the dry mouth shield and 5) gather patient feedback about the user experience with the dry mouth shield.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. reports of snoring that disturbed a bed partner or housemate and
•2. an objective measure of snoring such as a previous home sleep study, lab based polysomnography, or smart phone application with a snoring index of at least 20%

Exclusion Criteria

•1. Patient's with a body mass index of greater than 35 kilogram/meter squared.
•2. A history of chronic lung disease with permanently impaired lung function testing.
•3. A history of cardiovascular disease including but not limited to coronary artery disease or cerebrovascular disease.
•4. Current smokers.
•5. Patient's with a comorbid sleep disorder including but not limited to severe sleep apnea with an apnea hypopnea index of 30 events per hour, nocturnal hypoxia necessitating oxygen, current positive airway pressure use or restless legs syndrome
•6. Poor nasal patency in the judgment of the investigator
•7. Use of narcotics, benzodiazepines or other respiratory suppressing medication
•8. Females who are pregnant.

Locations (1)

Thomas Stern, MD

Huntersville, North Carolina, United States

Key Dates

Start Date

October 15, 2018

Primary Completion Date

January 31, 2019

Completion Date

January 31, 2019

Last Updated

April 27, 2022

Enrollment

ACTUAL participants

Conditions

Snoring

Interventions

DryMouth Shield

DEVICE

IOA Preventing Occlusal Changes With MAD Use

NCT07103941

View study

COMPLETEDNA

Does myTAP Oral Appliance Therapy Including a Mouth Shield Lessen Periodontitis in Mouth-Breathers Who Snore?

NCT06797089

SnoringMouth Breathing+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Effect of the DryMouth Shield on Snoring

Inclusion Criteria

Exclusion Criteria

IOA Preventing Occlusal Changes With MAD Use

Does myTAP Oral Appliance Therapy Including a Mouth Shield Lessen Periodontitis in Mouth-Breathers Who Snore?

Pilot Study of cNEP for the Treatment of Snoring

Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)

Adenotonsillectomy for Obstructive Sleep-Disordered Breathing in Childhood:The Chania Community Oximetry-Based Study

Apnea Hypopnea Index Severity Versus Head Position During Sleep