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NCT03579225 · ClinicalTrials.gov registry record
Improving the Efficiency of the Digital Sleep Workflow Using MATRx Plus
A clinical trial, sponsored by Zephyr Sleep Technologies.
- Completed
- Registry status
- 6
- Enrollment target
NCT03579225 is a clinical trial that has completed, run by Zephyr Sleep Technologies. The registered enrollment target is 6 participants.
The verdict
NCT03579225 has completed, sponsored by Zephyr Sleep Technologies.
- COMPLETED
- Registry status
- 6 participants
- Enrollment target
Study Summary
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients. Another treatment is to use an oral appliance in your mouth when you sleep. The appliance covers the upper and lower teeth and pulls the lower jaw forward, opening the airway and allowing normal breathing. Oral appliance treatment does not treat sleep apnea effectively in all patients. To identify patients for whom oral appliance therapy will work, Zephyr Sleep Technologies invented a device that tests various positions of the lower jaw from the comfort of your own home. The MATRx plus device is considered investigational since it has not been cleared by the U.S. FDA. During the MATRx plus test, the patient sleeps with a motorized positioner that moves the lower jaw. Jaw movement is automatically controlled by a computer, making the device a feedback controlled mandibular positioner. The purpose of the study is to test the workflow of the MATRx plus feedback controlled mandibular positioner in its intended setting. The workflow includes recruitment into the study, the screening process, visits at the dentist, home sleep tests, and the decision made regarding oral appliance therapy based on the results of the sleep tests. The main objective is to determine the turnaround time of a MATRx plus test in a real-use dental setting.
Interventions
- DEVICE MATRx plus test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2019-04-14 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03579225
The ClinicalTrials.gov registry entry for NCT03579225 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zephyr Sleep Technologies, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MATRx plus test is the first listed.
NCT03579225 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03579225 about?
NCT03579225 is a clinical study titled "Improving the Efficiency of the Digital Sleep Workflow Using MATRx Plus". Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients. Another treatment is to use...
What is the current status of trial NCT03579225?
This trial is currently completed. The enrollment target is 6 participants. The study started on 2018-07-01. Estimated completion is 2019-04-14.
What interventions are being tested in trial NCT03579225?
The interventions under investigation include: MATRx plus test (DEVICE).
Who is sponsoring clinical trial NCT03579225?
This trial is sponsored by Zephyr Sleep Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
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