NCT03701165

The Effect of the DryMouth Shield on Snoring

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: VMS Medical Products, Inc · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Snoring

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2018-10-09
• Last updated: 2022-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study