Validation of a Simplified MATRx Plus

NCT03812692 | Completed FDA Device

• 1 other identifier: ZCP201901
• Study Type: observational
• Target: 59
• 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 acts to pull the lower jaw forward, opening the throat passage and allowing normal breathing. Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has invented a feedback-controlled device that tests various positions of the lower jaw. This commercially available device, known as MATRx plus, is a Health Canada approved and FDA cleared motorized dental positioner that can be used in an overnight sleep study performed in the home. Temporary dental impression trays cover your upper and lower teeth. These are attached to a small motor that slowly and gently pulls your lower jaw forward under the control of a computer in response to real-time breathing events. The commercial MATRx plus device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse oximeter to guide the movement of the lower jaw during the test. Though the test is accurate, the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a simplified version of the test that requires fewer sensors and sleep time.

Conditions

Obstructive Sleep Apnea

Keywords

Oral appliance therapy

Outcome Measures

Primary Outcomes (1)

• Oxygen desaturation index

  With the oral appliance in place, participants will complete a 2-night home sleep apnea test with a Level III sleep recorder. The participant's oxygen desaturation index with the appliance will be recorded.

  6 weeks

Study Arms (1)

MATRx plus test

All participants will complete the MATRx plus test unattended in the home. Not all participants will be predicted responders to oral appliance therapy; both predicted responders and non-responders will undergo an outcome home sleep apnea test with a custom oral appliance in place to validate the prediction made by the test. Twenty participants will also complete an in-lab sleep study prior to the home study.

Device: MATRx plus

Interventions

MATRx plus DEVICE

The MATRx plus device is a feedback-controlled mandibular positioner that uses data collected during sleep to control movement of the mandible in real-time using a mandibular positioner. The test provides a prediction of the individual's response to oral appliance therapy; i.e., if the individual can treat his or her obstructive sleep apnea using a mandibular advancing oral appliance. For individuals predicted to respond to the therapy, the test also provides a mandibular position at which the appliance will be effective.

MATRx plus test

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be representative of the general population of individuals with obstructive sleep apnea in North America.

You may qualify if:

• Aged between 21 and 80 years
• Obstructive sleep apnea (ODI \> 10 h-1)
• Body mass index \< 45 kg/m2
• Neck circumference \< 50 cm
• Absence of severe oxyhemoglobin desaturation during sleep, indicated by a mean value of oxyhemoglobin saturation (SaO2) \> 87%
• Mandibular range of motion \> 5 mm
• Adequate dentition (10 upper and 10 lower teeth)
• Ability to understand and provide informed consent
• Ability and willingness to meet the required schedule

You may not qualify if:

• Inability to breathe comfortably through the nose
• Central Sleep Apnea (\> 50% of apneas are central)
• Anticipated change in medical therapy that could alter the severity of OSA during the protocol
• Anticipated change in body weight (5% or more) during the protocol
• Symptomatic, non-respiratory sleep disorder, e.g., restless leg syndrome or chronic insomnia
• Severe respiratory disorder(s) other than sleep disordered breathing
• Loose teeth, faulty restorations, or advanced periodontal disease
• Participation in other studies that could interfere with study protocol
• Pregnant or nursing
• Heart failure
• Cerebral vascular incident within the last 12 months
• Use of pacemaker or other life supporting device
• Regular use of CPAP or oral appliance therapy within 5 days of the PSG or HSAT (individuals on therapy wishing to participate may opt to cease therapy for the 5 nights prior to each test)

Sponsors & Collaborators

• Zephyr Sleep Technologies: lead

Study Sites (1)

Zephyr Sleep Technologies

Calgary, Alberta, T2H-2C3, Canada

Location

Related Publications (1)

• Mosca EV, Grosse J, Remmers JE. Oral appliance therapy is highly efficacious at reducing sleep apnea-specific hypoxic burden, a metric predictive of cardiovascular morbidity and mortality. J Clin Sleep Med. 2025 Jul 1;21(7):1185-1190. doi: 10.5664/jcsm.11622.

  PMID: 40123555 DERIVED

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: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: February 6, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 1, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)