Improving the Efficiency of the Digital Sleep Workflow Using MATRx Plus

NCT03579225 | Completed

• 1 other identifier: ZCP201801
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Device turnaround time

  Time from device deployment for MATRx plus test to device return (days).

  1 week

Study Arms (1)

MATRx plus test

Device: MATRx plus test

Interventions

MATRx plus test DEVICE

The MATRx plus is a home-based test that allows the healthcare provider to determine if a patient with obstructive sleep apnea will benefit from oral appliance therapy. Prior to the test, a dentist fits the patient with dental trays and measures the patient's comfortable jaw range of motion. The trays are connected to a mandibular positioner. During sleep, the device collects airflow from a nasal cannula and blood oxygen saturation from a pulse oximeter. These signals are used by the device software to control the mandibular positioner and protrude the mandible. During the test, the device moves the lower jaw within the patient's range of motion to predict if the patient is likely to benefit from oral appliance therapy and, if so, the appropriate amount of protrusion. Additional study nights may be required if the data from either of the first two nights are insufficient or if a more precise determination of the amount of jaw protrusion that provided a therapeutic benefit can be made.

MATRx plus test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from the Principal Investigator's population of patients.

You may qualify if:

• years of age
• suitable for oral appliance therapy
• ability to understand and provide informed consent
• ability and willingness to meet the required schedule

Sponsors & Collaborators

• Zephyr Sleep Technologies: lead

Study Sites (1)

Raleigh Dental Arts

Raleigh, North Carolina, 27613, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: July 1, 2018
• Primary Completion: April 14, 2019
• Study Completion: April 14, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)