The Effect of the DryMouth Shield on Snoring

NCT03701165 | Terminated FDA Device

• 1 other identifier: 2018-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

To measure the effect of the DryMouth Shield on snoring.

Conditions

Snoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Volume of snoring

  One night

Study Arms (1)

Snoring cohort.

OTHER

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

Interventions

DryMouth Shield DEVICE

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.

Also known as: Oral appliance

Snoring cohort.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• VMS Medical Products, Inc: lead

Study Sites (1)

Thomas Stern, MD

Huntersville, North Carolina, 28078, United States

Location

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: Cohort non-randomized trial.

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 9, 2018
• Study Start: October 15, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)