Workflow Validation of an In-Home Feedback Controlled Mandibular Positioner

NCT03616327 | Completed FDA Device

• 1 other identifier: ZCP201705
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to test the workflow of the MATRx and MATRx plus feedback controlled mandibular positioner in its intended setting and considerations related to decision making by the care provider. The workflow includes the participant's 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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Feasibility of MATRx plus use in a dental sleep medicine practice, as determined by successful completion of test

  Evaluation of the process to effectively coordinate the respective roles in the deployment of the sleep test. Feasibility will be determined by the ability for patients to complete the MATRx plus test.

  1 week

Secondary Outcomes (1)

• Patient satisfaction of test, as determined by feedback from the patients following the test.

  1 week

Study Arms (1)

MATRx in-lab or MATRx plus test

OTHER

Participants will undergo the MATRx in-lab or MATRx plus home test to determine adequacy for mandibular repositioning oral appliance therapy. The tests only differ in their setting (i.e., in the sleep lab or at home). All participants will receive the same treatment protocol preceding and following the MATRx/MATRx plus test.

Device: MATRx in-lab, MATRx plus

Interventions

MATRx in-lab, MATRx plus DEVICE

The MATRx remotely controlled mandibular positioner (RCMP) consists of temporary dental trays connected to an extra-oral linear actuator that protrudes the mandible. MATRx is used during polysomnography, where sleep and cardio-respiratory variables are recorded during sleep. The position of the mandible is controlled remotely by a sleep technologist, who moves the mandible while monitoring cardio-respiratory variables. The test determines if mandibular protrusion eliminates pharyngeal obstruction and the required protrusion. The MATRx plus is used in the home. Like the RCMP, the patient sleeps with the motorized mandibular positioner (MP) in place. However, the MP's position is controlled by a computer, making it a feedback controlled mandibular positioner (FCMP). The FCMP detects apneas and hypopneas in real time. Using this information, the controller decides when to move the mandible and by how much. The test predicts of therapeutic outcome with OA and provides a target protrusion.

MATRx in-lab or MATRx plus test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum 18 years of age
• Participant has been deemed suitable for oral appliance therapy
• Adequate mandibular range of motion
• Adequate dentition
• Ability to understand and provide informed consent
• Ability and willingness to meet the required schedule

You may not qualify if:

• Loose teeth or advanced periodontal disease
• Full dentures

Sponsors & Collaborators

• Zephyr Sleep Technologies: lead

Study Sites (1)

Charlotte Oral Surgery

Charlotte, North Carolina, 28207, 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 Officials

• Kent Moore, DDS, MD

  Charlotte Oral Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: August 6, 2018
• Study Start: November 1, 2017
• Primary Completion: August 15, 2019
• Study Completion: August 19, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

US (1)