Workflow Validation of an In-home Auto-titrating Mandibular Positioner
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/19/2018 |
| Start Date: | October 2016 |
| End Date: | October 11, 2018 |
The purpose of the study is to test the workflow of an auto-titrating mandibular positioner
in its intended setting. Participants with obstructive sleep apnea will use the device to
determine their eligibility for oral appliance therapy and provide feedback on usability of
the device.
in its intended setting. Participants with obstructive sleep apnea will use the device to
determine their eligibility for oral appliance therapy and provide feedback on usability of
the device.
One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an
appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening
the throat passage and allowing for normal breathing. However, oral appliance therapy does
not treat sleep apnea effectively in all individuals. In order to identify those individuals
for whom oral appliance therapy will work, the study sponsor has developed an investigational
device called an auto-titrating mandibular positioner. The device automatically pulls the
lower jaw forward in response to respiratory events while the individual sleeps. Study
participants will learn the outcome of their sleep tests and will provide feedback on the
ease of use of the device.
appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening
the throat passage and allowing for normal breathing. However, oral appliance therapy does
not treat sleep apnea effectively in all individuals. In order to identify those individuals
for whom oral appliance therapy will work, the study sponsor has developed an investigational
device called an auto-titrating mandibular positioner. The device automatically pulls the
lower jaw forward in response to respiratory events while the individual sleeps. Study
participants will learn the outcome of their sleep tests and will provide feedback on the
ease of use of the device.
Inclusion Criteria:
1. Minimum 18 years of age
2. Participant has been deemed suitable for oral appliance therapy
3. Prescription for oral appliance
4. Adequate range of motion
5. Adequate dentition
6. Ability to understand and provide informed consent
7. Ability and willingness to meet the required schedule
Exclusion Criteria:
1. Loose teeth or advanced periodontal disease
2. Full dentures or dental implants
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