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The Effect of the DryMouth Shield on Snoring

Primary Purpose

Snoring

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DryMouth Shield

About this trial

This is an interventional treatment trial for Snoring

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

reports of snoring that disturbed a bed partner or housemate and
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:

Patient's with a body mass index of greater than 35 kilogram/meter squared.
A history of chronic lung disease with permanently impaired lung function testing.
A history of cardiovascular disease including but not limited to coronary artery disease or cerebrovascular disease.
Current smokers.
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
Poor nasal patency in the judgment of the investigator
Use of narcotics, benzodiazepines or other respiratory suppressing medication
Females who are pregnant.

Sites / Locations

Thomas Stern, MD

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Snoring cohort.

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Volume of snoring

The mean volume of snoring as measured by a decibel meter.

Full Information

NCT ID

NCT03701165

First Posted

October 7, 2018

Last Updated

April 25, 2022

Sponsor

VMS Medical Products, Inc

1. Study Identification

Unique Protocol Identification Number

NCT03701165

Brief Title

The Effect of the DryMouth Shield on Snoring

Official Title

The Effect of the DryMouth Shield on Snoring

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Terminated

Why Stopped

VMS Medical went out of busainess

Study Start Date

October 15, 2018 (Actual)

Primary Completion Date

January 31, 2019 (Actual)

Study Completion Date

January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

VMS Medical Products, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Snoring

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Cohort non-randomized trial.

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Snoring cohort.

Arm Type

Other

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

DryMouth Shield

Other Intervention Name(s)

Oral appliance

Intervention Description

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.

Primary Outcome Measure Information:

Title

Frequency of snoring

Description

Time Frame

One night

Secondary Outcome Measure Information:

Title

Volume of snoring

Description

The mean volume of snoring as measured by a decibel meter.

Time Frame

One night

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: reports of snoring that disturbed a bed partner or housemate and 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: Patient's with a body mass index of greater than 35 kilogram/meter squared. A history of chronic lung disease with permanently impaired lung function testing. A history of cardiovascular disease including but not limited to coronary artery disease or cerebrovascular disease. Current smokers. 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 Poor nasal patency in the judgment of the investigator Use of narcotics, benzodiazepines or other respiratory suppressing medication Females who are pregnant.

Facility Information:

Facility Name

Thomas Stern, MD

City

Huntersville

State/Province

North Carolina

ZIP/Postal Code

28078

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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The Effect of the DryMouth Shield on Snoring

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