Snoring Clinical Trial
Official title:
The Effect of the DryMouth Shield on Snoring
Verified date | April 2022 |
Source | VMS Medical Products, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To measure the effect of the DryMouth Shield on snoring.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Stern, MD | Huntersville | North Carolina |
Lead Sponsor | Collaborator |
---|---|
VMS Medical Products, Inc |
United States,
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 |
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