The Effect of the DryMouth Shield on Snoring

To measure the effect of the DryMouth Shield on snoring.

Study Overview

• Status: Terminated
• Conditions: Snoring
• Intervention / Treatment: Device: DryMouth Shield

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Thomas Stern, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Snoring cohort.; Subjects will undergo two nights of polysomnography. The first night will be a baseline recording. The next night subjects will use the DryMouth Shield during the polysomnography.

Device: DryMouth Shield; The DryMouth Shield provides an elastomeric, one-piece design with breath-actuated, one-way valves configured to create an air-tight seal between the teeth and lips, which effectively reduces oral venting and air leakage while also allowing air flow into the mouth by generating a high-volume, low resistance airflow during inhalation while sealing when the user exhales.; Other Names: Oral appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of snoring	The percentage of number of snores during the sleep period relative to the total number of breaths during the same sleep period. A snore is defined as a breath during sleep accompanied by a vibratory noise louder than 40db	One night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of snoring	The mean volume of snoring as measured by a decibel meter.	One night

Collaborators and Investigators

• Sponsor: VMS Medical Products, Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 7, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring
• Other Study ID Numbers: 2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No