An interventional study of Auto-titrating mandibular positioner test in Obstructive Sleep Apnea, sponsored by Zephyr Sleep Technologies. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-07.
Sponsored by Zephyr Sleep Technologies · Not applicable, Interventional, and Other
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.
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.
1,422 studies on the registry are indexed under Apnea; 158 are open to participants now.
This study's enrollment of 28 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Zephyr Sleep Technologies is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All individuals will undergo a test using the auto-titrating mandibular positioner.
Device: Auto-titrating mandibular positioner test
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.
Integration of the device into the existing workflow of a dental sleep medicine practice
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.
Time frame: 6 months
Convenience/feasibility of carrying out a multi-night AMP study in the home
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).
Time frame: 6 months
Feasibility of instructing the participant on the use of the AMP device at the practitioner's office
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.
Time frame: 6 months
Time to therapy
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).
Time frame: 6 months
Number of study visits
The number of study visits will be recorded. This data will be collected from study records and does not require input from the participant.
Time frame: 6 months
Length of study visits
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.
Time frame: 6 months
Ease of scheduling study visits
The ease of scheduling will be discussed with the study staff to collect data on ease of integration of the device into the practice.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Zephyr Sleep Technologies