The Effect of the DryMouth Shield on Snoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Frequency of snoring
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Snoring cohort.
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: DryMouth Shield (Device)
Outcomes
Primary Outcomes
Frequency of snoring
Time Frame: 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 Outcomes
- Volume of snoring(One night)
Investigators
Thomas Stern, MD
Medical Director
VMS Medical Products, Inc