The Effect of the DryMouth Shield on Snoring

Snoring Clinical Trial

Official title:

The Effect of the DryMouth Shield on Snoring

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03701165
• Other study ID #: 2018-01
• Status: Terminated
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: April 2022
• Source: VMS Medical Products, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To measure the effect of the DryMouth Shield on snoring.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Snoring

Intervention

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.

Locations

Country	Name	City	State
United States	Thomas Stern, MD	Huntersville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VMS Medical Products, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Volume of snoring	The mean volume of snoring as measured by a decibel meter.	One night