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NCT03579225
Improving the Efficiency of the Digital Sleep Workflow Using MATRx Plus
trial testing MATRx plus test in Obstructive Sleep Apnea in 6 participants. Completed in 14 April 2019.
14 April 2019
Quick facts
| Lead sponsor | Zephyr Sleep Technologies |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 6 |
| Start date | 1 July 2018 |
| Primary completion | 14 April 2019 |
| Estimated completion | 14 April 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- MATRx plus test
Conditions studied
- Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
Sponsor
Zephyr Sleep Technologies
Who can join
18 and older, any sex, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03579225
- Europe PMC full search
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Related trials
Other recruiting trials for Obstructive Sleep Apnea
Currently open trials in the same condition.
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- NCT07273019 — Tongue Muscular Assessment in Children With Sleep Disordered Breathing · NA · recruiting
- NCT07447011 — Glaucoma Respsosne to Lifestyle Corrections in Sleep Apnea · NA · recruiting
- NCT07397780 — RPMO2 Oximeter Accuracy During Sleep 1 Trial · active not recruiting
- NCT06698809 — Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness · NA · recruiting
Other Zephyr Sleep Technologies trials
Trials by the same sponsor.
- NCT03812692 — Validation of a Simplified MATRx Plus · completed
- NCT03616327 — Workflow Validation of an In-Home Feedback Controlled Mandibular Positioner · NA · completed
- NCT03627169 — PSG Validation of MATRx Plus AHI · completed
- NCT03217383 — Predictive Accuracy of MATRx Plus in Identifying Favorable Candidates for Oral Appliance Therapy · NA · completed
- NCT03049982 — A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03579225 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zephyr Sleep Technologies
- Last refreshed: 18 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03579225.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing