Obstructive Sleep Apnea
Conditions
Keywords
oral appliance, sleep apnea, hypoxia
Brief summary
The purpose of this study is to evaluate the safety profile of the novel oral appliance (OA )device and to assess patient comfort of the novel OA device.
Interventions
DEVICENoval Oral Appliance
A scan of the mouth will be performed to make the oral device. The device will be 3D printed with Asiga UV Max printer using FDA 510(k) cleared VeriSplint OS Resin.Subjects will be will be asked to wear the oral device at night for 3 nights and fill out a survey reviewing their experience wearing the device.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* No history of obstructive sleep apnea * No active jaw joint pain * No active moderate to severe periodontal disease * Presence of 12 teeth per arch
Exclusion criteria
* presence of severe bruxism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety of device as measured by the number of patients with adverse events | During the time the OA device is worn, that is, from the time of appointment 2(1 month after enrollment) to the time of appointment 3 (1 week after appointment 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort of the novel OA device as measured by the delivery (pre care) patient feedback survey | 1 month after enrollment(appointment 2) | Comfort will be assessed through a numerical rating scale and short answer survey that will assess comfort and user feedback while wearing the novel OA device. There are 4 questions in the survey, the first one has 5 answer choices about how the appliance fits to the teeth and ranges from very tight fit to very loose fit .The rest of the questions are rated form 1-10,a higher number indicating more comfort |
| Comfort of the novel OA device as measured by the post care patient feedback survey | 1 week after appointment 2(appointment 3) | Comfort will be assessed through a numerical rating scale and short answer survey that will assess comfort and user feedback while wearing the novel OA device.There are 12 questions in the survey, the first one has 5 answer choices about how the appliance fits to the teeth and ranges from very tight fit to very loose fit .The next 8 questions are rated form 1-10,a higher number indicating more comfort, the 9th question indicates any adverse events and the last 3 questions are short answer questions describing the patient's experience with the device. |
Countries
United States
Outcome results
None listed