Snoring
Conditions
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.
Interventions
DEVICEDryMouth 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.
Sponsors
VMS Medical Products, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cohort non-randomized trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of snoring | One night | 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
| Measure | Time frame | Description |
|---|---|---|
| Volume of snoring | One night | The mean volume of snoring as measured by a decibel meter. |
Countries
United States
Outcome results
None listed