Obstructive Sleep Apnea
Conditions
Keywords
Oral appliance therapy
Brief summary
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.
Detailed description
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.
Interventions
Participants will undergo a theragnostic test using the auto-titrating mandibular positioner to determine if they are eligible candidates to use oral appliance therapy for their obstructive sleep apnea. The device works by moving the lower jaw forward in response to respiratory events while the participant sleeps. All participants will undergo the same test.
Sponsors
Zephyr Sleep Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Integration of the device into the existing workflow of a dental sleep medicine practice | 6 months | Data for this outcome are largely directed at the study staff, not study participants. Data collected for this outcome include: time required to evaluate eligibility for device use, time required to prepare device for use. |
| Convenience/feasibility of carrying out a multi-night AMP study in the home | 6 months | Participants will complete a questionnaire following their AMP tests to collect data on participants' opinion of the device (includes opinion of various device components, ease of use of the device). |
| Feasibility of instructing the participant on the use of the AMP device at the practitioner's office | 6 months | Data for this outcome are directed at study staff, not study participants. Data collected will include feedback on ease of training participants on device use. Participants will be asked if they felt they received adequate training from the study staff via a questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to therapy | 6 months | Time to therapy will be evaluated by tracking the time from the first consultation at the dentist's office to the setting of the temporary appliance (for individuals whose tests indicate they are predicted candidates for oral appliance therapy). |
| Ease of scheduling study visits | 6 months | The ease of scheduling will be discussed with the study staff to collect data on ease of integration of the device into the practice. |
| Number of study visits | 6 months | The number of study visits will be recorded. This data will be collected from study records and does not require input from the participant. |
| Length of study visits | 6 months | The length of each visit (minutes) will be recorded. This data will be collected from study records and does not require input from the participant. |
Countries
United States
Outcome results
None listed