Sleep Apnea Syndromes, Snoring
Conditions
Brief summary
Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.
Detailed description
The Keepasleep airway device is a novel and unique buccopharyngeal airway device to enhance breathing during sleep. This method has not been described in the medical literature and has been successful in limited testing. This clinical trial is to determine the safety and effectiveness of the KEEPASLEEP device utilizing 30 subjects with simple snoring. Each subject will serve as his/her own control. The device augments airflow into the posterior pharynx to minimize airway collapse,tissue vibration, and consequent snoring.The device passes through the retromaxillary space and requires that the subject be absent their wisdom teeth.
Interventions
DEVICEKEEPASLEEP enhanced breathing device
Sponsors
Miller, Chipp St. Kevin, M.D.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- 18 yrs. of age or greater * generally good health * Intact dentition / ABSENT upper and lower wisdom teeth ( by extraction or lack of development ) * Simple snoring( documented by observer) or mild sleep apnea RDI \< 15 ( documented by polysomnogram) * Subject must have a concerned observer to assess of sleep and snoring behavior during trial period
Exclusion criteria
- Presence of Wisdom teeth (third molars) * active oral disease * acute illness * BMI (body mass index) \> 30
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction/Elimination of snoring behavior | — |
Countries
United States
Contacts
Primary ContactChipp K. Miller, M.D.
Outcome results
None listed